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CompletedNCT03371017IMpassion132Updated Nov 12, 2025Results posted

A Study of the Efficacy and Safety of Atezolizumab Plus Chemotherapy for Patients With Early Relapsing Recurrent Triple-Negative Breast Cancer

A Phase 3 interventional study of Atezolizumab and Placebo in Triple Negative Breast Neoplasms, sponsored by Hoffmann-La Roche. Completed at 124 sites in 28 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-12.

Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
595
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study will evaluate the efficacy and safety of atezolizumab plus chemotherapy compared with placebo plus chemotherapy in patients with inoperable recurrent triple-negative breast cancer (TNBC).

02

Conditions studied

  • Triple Negative Breast Neoplasms
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Histologically confirmed triple negative breast cancer (TNBC) that is either locally recurrent, inoperable and cannot be treated with curative intent or is metastatic
  • Documented disease progression occurring within 12 months from the last treatment with curative intent
  • Prior treatment (of early breast cancer) with an anthracycline and taxane
  • Have not received prior chemotherapy or targeted systemic therapy for their locally advanced inoperable or metastatic recurrence. Prior radiation therapy for recurrent disease is permitted
  • Measurable or non-measurable disease, as defined by RECIST 1.1
  • Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumour block (preferred) or at least 17 unstained slides obtained from relapsed metastatic or locally advanced diseases may be submitted, if clinically feasible, with an associated pathology report, if available. If a fresh tumour sample is not clinically feasible, either the diagnosis sample, the primary surgical resection sample, or the most recent FFPE tumour biopsy sample should be used.
  • Eastern Cooperative Oncology Group performance status 0-1
  • Life expectancy ≥ 12 weeks
  • Adequate haematologic and end-organ function
  • Negative human immunodeficiency virus (HIV) test ---Negative hepatitis B surface antigen (HBsAg) test at screening
  • Negative total hepatitis B core antibody (HBcAb) test at screening, or positive HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening
  • The HBV DNA test will be performed only for patients who have a negative HBsAg and a positive HBcAb test.
  • Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening.
  • Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of ≤1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab or 6 months after the last dose of capecitabine, whichever is later. In addition, women must refrain from donating eggs during the same time period.
  • Men must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agree to refrain from donating sperm

Inclusion criteria for patients enrolled after the recruitment of all-comers is complete:

-PD-L1-positive tumour status (assessed centrally prior to randomisation), defined as PD-L1 expression on tumour-infiltrating immune cells (IC) of 1% or greater.

Exclusion Criteria:

  • Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for > 2 weeks prior to randomisation
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
  • Symptomatic or rapid visceral progression
  • No prior treatment with an anthracycline and taxane
  • History of leptomeningeal disease
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) (patients with indwelling catheters such as PleurX® are allowed)
  • Uncontrolled tumour-related pain
  • Uncontrolled or symptomatic hypercalcemia
  • Malignancies other than TNBC within 5 years prior to randomisation)
  • Significant cardiovascular disease, within 3 months prior to randomisation, unstable arrhythmias, or unstable angina
  • Presence of an abnormal ECG
  • Severe infection requiring oral or IV antibiotics within 4 weeks prior to randomisation, including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia.
  • Current treatment with anti-viral therapy for HBV.
  • Major surgical procedure within 4 weeks prior to randomisation or anticipation of the need for a major surgical procedure during the course of the study other than for diagnosis
  • Treatment with investigational therapy within 28 days prior to randomisation
  • Pregnant or lactating, or intending to become pregnant during or within 5 months after the last dose of atezolizumab, or within 6 months after the last dose of capecitabine, whichever is later.

Exclusion Criteria Related to Atezolizumab:

  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanised antibodies or fusion proteins
  • Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or to any component of the atezolizumab formulation
  • History of autoimmune disease
  • Prior allogeneic stem cell or solid organ transplantation
  • History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e. bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest computerised tomography (CT) scan History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
  • Active tuberculosis
  • Receipt of a live, attenuated vaccine within 4 weeks prior to randomisation or anticipation that a live, attenuated vaccine will be required during atezolizumab/placebo treatment or within 5 months after the last dose of atezolizumab/placebo
  • Prior treatment with CD137 agonists, anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway targeting agents
  • Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin [IL]-2) within 4 weeks or five half-lives of the drug (whichever is longer) prior to randomisation
  • Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to start of study treatment, or anticipated requirement for systemic immunosuppressive medications during the trial

Exclusion Criteria Related to Capecitabine:

  • Inability to swallow pills
  • Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach or small bowel, or ulcerative colitis
  • Known dihydropyrimidine dehydrogenase (DPD) deficiency or history of severe and unexpected reactions to fluoropyrimidine therapy in patients selected to receive capecitabine

Exclusion Criteria Related to Carboplatin/Gemcitabine:

-Hypersensitivity to platinum containing compounds or any component of carboplatin or gemcitabine drug formulations in patients selected to receive carboplatin and Gemcitabine

04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
595 participants (actual)

Study arms

  • Experimental
    Atezolizumab

    Participants will receive Atezolizumab on day 1 of each 3-week treatment cycle

    Drug: Atezolizumab · Drug: Gemcitabine · Drug: Capecitabine · Drug: Carboplatin

  • Placebo comparator
    Placebo

    Participants will receive Placebo on day 1 of each 3-week treatment cycle

    Drug: Placebo · Drug: Gemcitabine · Drug: Capecitabine · Drug: Carboplatin

Interventions

  • DrugAtezolizumab

    Atezolizumab will be administered, 1200 mg by IV infusion with : gemcitabine 1000 mg/m2, followed by carboplatin target area under the curve (AUC) 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each 3-week treatment cycle or with capecitabine 1000 mg/m2, twice daily orally on Days 1 to 14, followed by a 7-day rest period in each 3-week treatment cycle

  • DrugPlacebo

    Placebo will be administered, 1200 mg by IV infusion with : gemcitabine 1000 mg/m2, followed by carboplatin target area under the curve (AUC) 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each 3-week treatment cycle or with capecitabine 1000 mg/m2, twice daily orally on Days 1 to 14, followed by a 7-day rest period in each 3-week treatment cycle

  • DrugGemcitabine

    Gemcitabine 1000 mg/m2, followed by carboplatin target area under the curve (AUC) 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each 3-week treatment cycle

  • DrugCapecitabine

    Capecitabine 1000 mg/m2, twice daily orally on Days 1 to 14, followed by a 7-day rest period in each 3-week treatment cycle

  • DrugCarboplatin

    Carboplatin target area under the curve (AUC) 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each 3-week treatment cycle

05

What researchers measure

Primary outcomes

  1. Overall Survival (OS) in PD-L1-positive Population

    OS was defined as time from randomization to death from any cause. Participants without a reported death event at the time of the analysis were censored on the date they were last known to be alive. If no post-baseline data were available, OS was censored at the date of randomization +1 day.

    Time frame: Time from randomization to death (Up to 68 months)

  2. OS in Modified Intent-to-treat (mITT) Population

    OS was defined as time from randomization to death from any cause. Participants without a reported death event at the time of the analysis were censored on the date they were last known to be alive. If no post-baseline data were available, OS was censored at the date of randomization +1 day.

    Time frame: Time from randomization to death (Up to 68 months)

Secondary outcomes

  1. 12-month Survival Rate in PD-L1-positive Population

    12-month survival rate was defined as the percentage of participants alive 12 months after randomization. The 12-month survival rates were estimated by Kaplan-Meier methodology. Percentages have been rounded off to the nearest whole number.

    Time frame: 12 months

  2. 12-month Survival Rate in mITT Population

    12-month survival rate was defined as the percentage of participants alive 12 months after randomization. The 12-month survival rates were estimated by Kaplan-Meier methodology. Percentages have been rounded off to nearest whole number.

    Time frame: 12 months

  3. 18-month Survival Rate in PD-L1-positive Population

    18-month survival rate was defined as the percentage of participants alive 18 months after randomization. The 18-month survival rates were estimated by Kaplan-Meier methodology. Percentages have been rounded off to nearest whole number.

    Time frame: 18 months

  4. 18-month Survival Rate in mITT Population

    18-month survival rate was defined as the percentage of participants alive 18 months after randomization. The 18-month survival rates were estimated by Kaplan-Meier methodology. Percentages have been rounded off to nearest whole number.

    Time frame: 18 months

  5. Progression-free Survival (PFS) in PD-L1-positive Population

    PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 millimeters (mm). Data for participants not experiencing PD or death were censored at the last tumour assessment date. If no tumor assessment was performed after randomisation, data were censored at the date of randomisation +1 day.

    Time frame: Time from randomization to the first occurrence of PD or death (Up to 68 months)

  6. PFS in mITT Population

    PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Data for participants not experiencing PD or death were censored at the last tumour assessment date. If no tumor assessment was performed after randomisation, data were censored at the date of randomisation +1 day.

    Time frame: Time from randomization to the first occurrence of PD or death (Up to 68 months)

  7. Objective Response Rate (ORR) in Response-evaluable Population, Subset of PD-L1-positive Population

    ORR was defined as percentage of participants with measurable disease at baseline who achieved a documented unconfirmed objective response (OR). OR was defined as either a complete response (CR) or a partial response (PR), as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off to nearest whole number.

    Time frame: Baseline up to end of study (Up to 68 months)

  8. ORR in Response-evaluable Population, Subset of mITT Population

    ORR was defined as percentage of participants with measurable disease at baseline who achieved a documented unconfirmed OR. OR was defined as either a CR or PR, as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off to nearest whole number.

    Time frame: Baseline up to end of study (Up to 68 months)

  9. Duration of Objective Response (DoR) in DoR-evaluable Population Subset of PD-L1-positive Population

    DoR was defined as the time from the first occurrence of a documented unconfirmed response (CR or PR) until the date of PD as determined by the investigator from tumor assessments using RECIST v1.1 or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.

    Time frame: Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months)

  10. DoR in DoR-evaluable Population Subset of mITT Population

    DoR was defined as the time from the first occurrence of a documented unconfirmed response (CR or PR) until the date of PD as determined by the investigator from tumor assessments using RECIST v1.1 or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.

    Time frame: Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months)

  11. Clinical Benefit Rate (CBR) in Response-evaluable Population Subset of PD-L1-positive Population

    CBR was defined as the percentage of participants with either an unconfirmed CR or PR or stable disease (SD) that lasts at least 6 months as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Percentages have been rounded off to nearest whole number.

    Time frame: Up to 68 months

  12. CBR in Response-evaluable Population Subset of mITT Population

    CBR was defined as the percentage of participants with either an unconfirmed CR or PR or SD that lasts at least 6 months as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Percentages have been rounded off to nearest whole number.

    Time frame: Up to 68 months

  13. Confirmed Objective Response Rate (C-ORR) in Response-evaluable Population Subset of PD-L1-positive Population

    C-ORR was defined as percentage of participants with measurable disease at baseline who achieved a documented confirmed OR. OR was defined as either a CR or PR, as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off to nearest whole number.

    Time frame: Up to 68 months

  14. C-ORR in Response-evaluable Population Subset of mITT Population

    C-ORR was defined as percentage of participants with measurable disease at baseline who achieved a documented confirmed OR. OR was defined as either a CR or PR, as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off to nearest whole number.

    Time frame: Up to 68 months

  15. DoR for Confirmed Responders (C-DoR) in C-DoR-evaluable Population Subset of PD-L1-positive Population

    C-DoR was defined as the time from the first occurrence of a documented confirmed response (CR or PR) until the date of PD as determined by the investigator from tumor assessments using RECIST v1.1 or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.

    Time frame: Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months)

  16. C-DoR in C-DoR-evaluable Population Subset of mITT Population

    C-DoR was defined as the time from the first occurrence of a documented confirmed response (CR or PR) until the date of PD as determined by the investigator from tumor assessments using RECIST v1.1 or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.

    Time frame: Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months)

  17. Time to Confirmed Deterioration (TTD) in Global Health Status/Quality of Life (GHS/QoL) According to the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) in PD-L1-positive Population

    TTD in GHS/QoL, defined by a minimally important decrease of ≥10 points at 2 consecutive assessment time-points on the GHS/QoL scale (Items 29, 30) of EORTC QLQ-C30, which consists of 30 questions that assess 5 aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, \& six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Participant responses to questions regarding GHS (Question 29: GHS; "How would you rate your overall health during the past week?") \& QoL (Question 30: QoL; "How would you rate your overall quality of life during the past week?") were assessed \& were scored on a 7-point scale (1= Very poor; 7=Excellent). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating better QoL.

    Time frame: Up to 68 months

  18. TTD in GHS/QoL According to EORTC QLQ-C30 in mITT Population

    TTD in GHS/QoL, defined by a minimally important decrease of ≥10 points at 2 consecutive assessment time-points on the GHS/QoL scale (Items 29, 30) of EORTC QLQ-C30, which consists of 30 questions that assess 5 aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, \& six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Participant responses to questions regarding GHS (Question 29: GHS; "How would you rate your overall health during the past week?") \& QoL (Question 30: QoL; "How would you rate your overall quality of life during the past week?") were assessed \& were scored on a 7-point scale (1= Very poor; 7=Excellent). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating better QoL.

    Time frame: Up to 68 months

  19. Number of Participants With Adverse Events (AEs)

    An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions that worsen during a study are also considered AEs.

    Time frame: From treatment initiation up to 90 days after last dose (up to 71 months)

  20. Serum Concentration of Atezolizumab

    Time frame: Pre-dose on Day 1 of Cycles 1, 2, 3 and 4; Post-dose on Day 1 of Cycles 1 and 3 and Treatment Discontinuation Visit (up to 69 months) (1 Cycle= 3 weeks)

  21. Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab

    Number of ADA-positive participants after drug administration was determined for participants exposed to atezolizumab. For determining post-baseline incidence, participants were considered to be ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following study drug exposure, or if they were ADA-positive at baseline and the titer of 1 or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the baseline titer result. The sum of participants who were ADA-positive at postbaseline visits of Cycles 1 to 4 and treatment discontinuation has been reported here.

    Time frame: Cycles 1 to 4 and Treatment Discontinuation visit (up to 69 months)

  22. Number of Participants With PD-L1 Protein Expression in Screening Tumour Tissue and Post-baseline Assessment

    Time frame: Baseline up to 68 months

Other outcomes

  1. OS in China Population

    OS was defined as time from randomization to death from any cause.

    Time frame: Time from randomization to death (Up to 68 months)

  2. 12-month Survival Rate in China Population

    12-month survival rate was defined as the percentage of participants alive 12 months after randomization.

    Time frame: 12 months

  3. 18-month Survival Rate in China Population

    18-month survival rate was defined as the percentage of participants alive 18 months after randomization.

    Time frame: 18 months

  4. PFS in China Population

    PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST 1.1, or death from any cause, whichever occurs first.

    Time frame: Time from randomization to the first occurrence of PD or death (Up to 68 months)

  5. ORR in China Population

    ORR was defined as percentage of participants with measurable disease at baseline who achieved a documented unconfirmed OR. OR was defined as either a CR or PR, as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR.

    Time frame: Baseline up to end of study (Up to 68 months)

  6. DoR in China Population

    DoR was defined as the time from the first occurrence of a documented unconfirmed response (CR or PR) until the date of PD as determined by the investigator from tumor assessments using RECIST v1.1 or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.

    Time frame: Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months)

  7. CBR in China Population

    CBR was defined as the percentage of participants with either an unconfirmed CR or PR or SD that lasts at least 6 months as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm.

    Time frame: Up to 68 months

  8. C-ORR in China Population

    C-ORR was defined as percentage of participants with measurable disease at baseline who achieved a documented confirmed OR. OR was defined as either a CR or PR, as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR.

    Time frame: Up to 68 months

  9. C-DoR in China Population

    C-DoR was defined as the time from the first occurrence of a documented confirmed response (CR or PR) until the date of PD as determined by the investigator from tumor assessments using RECIST v1.1 or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.

    Time frame: Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months)

  10. TTD in GHS/QoL According to EORTC QLQ-C30 in China Population

    TTD in GHS/QoL, defined by a minimally important decrease of ≥10 points at 2 consecutive assessment time-points on the GHS/QoL scale (Items 29, 30) of EORTC QLQ-C30, which consists of 30 questions that assess 5 aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, \& six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Participant responses to questions regarding GHS (Question 29: GHS; "How would you rate your overall health during the past week?") \& QoL (Question 30: QoL; "How would you rate your overall quality of life during the past week?") were assessed \& were scored on a 7-point scale (1= Very poor; 7=Excellent). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating better QoL.

    Time frame: Up to 68 months

06

Results

Posted Nov 12, 2025

Participant flow

A total of 595 participants with inoperable locally advanced or metastatic Triple-negative Breast Cancer (TNBC) took part in the study at 126 investigative sites in 28 countries from 11 January 2018 to 23 October 2024.

Participant flow — Overall Study
MilestonePlacebo + ChemotherapyAtezolizumab + Chemotherapy
Started298297
Safety-evaluable population294293
Programmed death-ligand 1 (pd-l1)-positive population177177
Modified intent-to-treat (mitt) population192188
Completed00
Not completed298297
Withdrew: Physician decision01
Withdrew: Reason not specified01
Withdrew: Lost to follow-up1316
Withdrew: Death228215
Withdrew: Withdrawal by subject2025
Withdrew: Study ended by sponsor3738
Withdrew: Protocol deviation01

Outcome measures

PrimaryOverall Survival (OS) in PD-L1-positive Population

OS was defined as time from randomization to death from any cause. Participants without a reported death event at the time of the analysis were censored on the date they were last known to be alive. If no post-baseline data were available, OS was censored at the date of randomization +1 day.

Time frame:
Time from randomization to death (Up to 68 months)
Reported as:
Median · months
Overall Survival (OS) in PD-L1-positive Population
monthsPlacebo + ChemotherapyAtezolizumab + Chemotherapy
Overall Survival (OS) in PD-L1-positive Population11.24 (9.00 to 13.31)12.09 (10.12 to 15.08)
Statistical analysis
  • Placebo + Chemotherapy vs Atezolizumab + Chemotherapy · Log Rank · p = 0.5891 · Hazard ratio (hr): 0.93 · 95% CI 0.73 to 1.20
PrimaryOS in Modified Intent-to-treat (mITT) Population

OS was defined as time from randomization to death from any cause. Participants without a reported death event at the time of the analysis were censored on the date they were last known to be alive. If no post-baseline data were available, OS was censored at the date of randomization +1 day.

Time frame:
Time from randomization to death (Up to 68 months)
Reported as:
Median · months
OS in Modified Intent-to-treat (mITT) Population
monthsPlacebo + ChemotherapyAtezolizumab + Chemotherapy
OS in Modified Intent-to-treat (mITT) Population9.79 (8.44 to 11.96)10.35 (8.90 to 12.88)
Statistical analysis
  • Placebo + Chemotherapy vs Atezolizumab + Chemotherapy · Log Rank · p = 0.6139 · Hazard ratio (hr): 0.94 · 95% CI 0.76 to 1.18
Secondary12-month Survival Rate in PD-L1-positive Population

12-month survival rate was defined as the percentage of participants alive 12 months after randomization. The 12-month survival rates were estimated by Kaplan-Meier methodology. Percentages have been rounded off to the nearest whole number.

Time frame:
12 months
Reported as:
Number · percentage of participants
12-month Survival Rate in PD-L1-positive Population
percentage of participantsPlacebo + ChemotherapyAtezolizumab + Chemotherapy
12-month Survival Rate in PD-L1-positive Population47.58 (39.92 to 55.23)50.26 (42.61 to 57.91)
Statistical analysis
  • Placebo + Chemotherapy vs Atezolizumab + Chemotherapy · Z-test · p = 0.6264 · Difference in event free rate: 2.69 · 95% CI -8.14 to 13.51
Secondary12-month Survival Rate in mITT Population

12-month survival rate was defined as the percentage of participants alive 12 months after randomization. The 12-month survival rates were estimated by Kaplan-Meier methodology. Percentages have been rounded off to nearest whole number.

Time frame:
12 months
Reported as:
Number · percentage of participants
12-month Survival Rate in mITT Population
percentage of participantsPlacebo + ChemotherapyAtezolizumab + Chemotherapy
12-month Survival Rate in mITT Population42.44 (35.23 to 49.66)46.20 (38.84 to 53.56)
Statistical analysis
  • Placebo + Chemotherapy vs Atezolizumab + Chemotherapy · Z-test · p = 0.4750 · Difference in event free rate: 3.76 · 95% CI -6.55 to 14.07
Secondary18-month Survival Rate in PD-L1-positive Population

18-month survival rate was defined as the percentage of participants alive 18 months after randomization. The 18-month survival rates were estimated by Kaplan-Meier methodology. Percentages have been rounded off to nearest whole number.

Time frame:
18 months
Reported as:
Number · percentage of participants
18-month Survival Rate in PD-L1-positive Population
percentage of participantsPlacebo + ChemotherapyAtezolizumab + Chemotherapy
18-month Survival Rate in PD-L1-positive Population32.48 (25.07 to 39.89)33.63 (26.05 to 41.21)
Statistical analysis
  • Placebo + Chemotherapy vs Atezolizumab + Chemotherapy · Z-test · p = 0.8315 · Difference in event free rate: 1.15 · 95% CI -9.45 to 11.75
Secondary18-month Survival Rate in mITT Population

18-month survival rate was defined as the percentage of participants alive 18 months after randomization. The 18-month survival rates were estimated by Kaplan-Meier methodology. Percentages have been rounded off to nearest whole number.

Time frame:
18 months
Reported as:
Number · percentage of participants
18-month Survival Rate in mITT Population
percentage of participantsPlacebo + ChemotherapyAtezolizumab + Chemotherapy
18-month Survival Rate in mITT Population25.68 (19.15 to 32.21)27.05 (20.39 to 33.71)
Statistical analysis
  • Placebo + Chemotherapy vs Atezolizumab + Chemotherapy · Z-test · p = 0.7738 · Difference in event free rate: 1.37 · 95% CI -7.96 to 10.69
SecondaryProgression-free Survival (PFS) in PD-L1-positive Population

PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 millimeters (mm). Data for participants not experiencing PD or death were censored at the last tumour assessment date. If no tumor assessment was performed after randomisation, data were censored at the date of randomisation +1 day.

Time frame:
Time from randomization to the first occurrence of PD or death (Up to 68 months)
Reported as:
Median · months
Progression-free Survival (PFS) in PD-L1-positive Population
monthsPlacebo + ChemotherapyAtezolizumab + Chemotherapy
Progression-free Survival (PFS) in PD-L1-positive Population3.58 (3.35 to 4.17)4.21 (3.71 to 5.62)
Statistical analysis
  • Placebo + Chemotherapy vs Atezolizumab + Chemotherapy · Log Rank · p = 0.1387 · Hazard ratio (hr): 0.84 · 95% CI 0.67 to 1.06
SecondaryPFS in mITT Population

PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Data for participants not experiencing PD or death were censored at the last tumour assessment date. If no tumor assessment was performed after randomisation, data were censored at the date of randomisation +1 day.

Time frame:
Time from randomization to the first occurrence of PD or death (Up to 68 months)
Reported as:
Median · months
PFS in mITT Population
monthsPlacebo + ChemotherapyAtezolizumab + Chemotherapy
PFS in mITT Population3.58 (3.06 to 3.81)3.71 (2.83 to 4.01)
Statistical analysis
  • Placebo + Chemotherapy vs Atezolizumab + Chemotherapy · Log Rank · p = 0.7317 · Hazard ratio (hr): 0.96 · 95% CI 0.78 to 1.19
SecondaryObjective Response Rate (ORR) in Response-evaluable Population, Subset of PD-L1-positive Population

ORR was defined as percentage of participants with measurable disease at baseline who achieved a documented unconfirmed objective response (OR). OR was defined as either a complete response (CR) or a partial response (PR), as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off to nearest whole number.

Time frame:
Baseline up to end of study (Up to 68 months)
Reported as:
Number · percentage of participants
Objective Response Rate (ORR) in Response-evaluable Population, Subset of PD-L1-positive Population
percentage of participantsPlacebo + ChemotherapyAtezolizumab + Chemotherapy
Objective Response Rate (ORR) in Response-evaluable Population, Subset of PD-L1-positive Population28.3 (21.45 to 35.98)39.6 (31.83 to 47.80)
Statistical analysis
  • Placebo + Chemotherapy vs Atezolizumab + Chemotherapy · Cochran-Mantel-Haenszel · p = 0.0337 · Difference in orr: 11.31 · 95% CI 0.24 to 22.37
SecondaryORR in Response-evaluable Population, Subset of mITT Population

ORR was defined as percentage of participants with measurable disease at baseline who achieved a documented unconfirmed OR. OR was defined as either a CR or PR, as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off to nearest whole number.

Time frame:
Baseline up to end of study (Up to 68 months)
Reported as:
Number · percentage of participants
ORR in Response-evaluable Population, Subset of mITT Population
percentage of participantsPlacebo + ChemotherapyAtezolizumab + Chemotherapy
ORR in Response-evaluable Population, Subset of mITT Population32.1 (25.16 to 39.77)31.0 (24.16 to 38.51)
Statistical analysis
  • Placebo + Chemotherapy vs Atezolizumab + Chemotherapy · Cochran-Mantel-Haenszel · p = 0.9755 · Difference in orr: -1.15 · 95% CI -11.63 to 9.34
SecondaryDuration of Objective Response (DoR) in DoR-evaluable Population Subset of PD-L1-positive Population

DoR was defined as the time from the first occurrence of a documented unconfirmed response (CR or PR) until the date of PD as determined by the investigator from tumor assessments using RECIST v1.1 or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.

Time frame:
Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months)
Reported as:
Median · months
Duration of Objective Response (DoR) in DoR-evaluable Population Subset of PD-L1-positive Population
monthsPlacebo + ChemotherapyAtezolizumab + Chemotherapy
Duration of Objective Response (DoR) in DoR-evaluable Population Subset of PD-L1-positive Population4.14 (3.45 to 5.78)6.60 (4.63 to 8.02)
Statistical analysis
  • Placebo + Chemotherapy vs Atezolizumab + Chemotherapy · Log Rank · p = 0.1359 · Hazard ratio (hr): 0.73 · 95% CI 0.48 to 1.11
SecondaryDoR in DoR-evaluable Population Subset of mITT Population

DoR was defined as the time from the first occurrence of a documented unconfirmed response (CR or PR) until the date of PD as determined by the investigator from tumor assessments using RECIST v1.1 or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.

Time frame:
Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months)
Reported as:
Median · months
DoR in DoR-evaluable Population Subset of mITT Population
monthsPlacebo + ChemotherapyAtezolizumab + Chemotherapy
DoR in DoR-evaluable Population Subset of mITT Population5.22 (3.81 to 6.60)5.70 (4.17 to 7.92)
Statistical analysis
  • Placebo + Chemotherapy vs Atezolizumab + Chemotherapy · Log Rank · p = 0.8225 · Hazard ratio (hr): 0.95 · 95% CI 0.63 to 1.43
SecondaryClinical Benefit Rate (CBR) in Response-evaluable Population Subset of PD-L1-positive Population

CBR was defined as the percentage of participants with either an unconfirmed CR or PR or stable disease (SD) that lasts at least 6 months as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Percentages have been rounded off to nearest whole number.

Time frame:
Up to 68 months
Reported as:
Number · percentage of participants
Clinical Benefit Rate (CBR) in Response-evaluable Population Subset of PD-L1-positive Population
percentage of participantsPlacebo + ChemotherapyAtezolizumab + Chemotherapy
Clinical Benefit Rate (CBR) in Response-evaluable Population Subset of PD-L1-positive Population34.6 (27.23 to 42.53)42.9 (34.92 to 51.07)
SecondaryCBR in Response-evaluable Population Subset of mITT Population

CBR was defined as the percentage of participants with either an unconfirmed CR or PR or SD that lasts at least 6 months as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Percentages have been rounded off to nearest whole number.

Time frame:
Up to 68 months
Reported as:
Number · percentage of participants
CBR in Response-evaluable Population Subset of mITT Population
percentage of participantsPlacebo + ChemotherapyAtezolizumab + Chemotherapy
CBR in Response-evaluable Population Subset of mITT Population36.3 (29.04 to 44.07)35.1 (27.96 to 42.74)
SecondaryConfirmed Objective Response Rate (C-ORR) in Response-evaluable Population Subset of PD-L1-positive Population

C-ORR was defined as percentage of participants with measurable disease at baseline who achieved a documented confirmed OR. OR was defined as either a CR or PR, as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off to nearest whole number.

Time frame:
Up to 68 months
Reported as:
Number · percentage of participants
Confirmed Objective Response Rate (C-ORR) in Response-evaluable Population Subset of PD-L1-positive Population
percentage of participantsPlacebo + ChemotherapyAtezolizumab + Chemotherapy
Confirmed Objective Response Rate (C-ORR) in Response-evaluable Population Subset of PD-L1-positive Population19.5 (13.65 to 26.52)31.2 (23.96 to 39.12)
Statistical analysis
  • Placebo + Chemotherapy vs Atezolizumab + Chemotherapy · Cochran-Mantel-Haenszel · p = 0.0172 · Difference in orr: 11.67 · 95% CI 1.47 to 21.87
SecondaryC-ORR in Response-evaluable Population Subset of mITT Population

C-ORR was defined as percentage of participants with measurable disease at baseline who achieved a documented confirmed OR. OR was defined as either a CR or PR, as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off to nearest whole number.

Time frame:
Up to 68 months
Reported as:
Number · percentage of participants
C-ORR in Response-evaluable Population Subset of mITT Population
percentage of participantsPlacebo + ChemotherapyAtezolizumab + Chemotherapy
C-ORR in Response-evaluable Population Subset of mITT Population23.2 (17.06 to 30.34)23.4 (17.27 to 30.46)
Statistical analysis
  • Placebo + Chemotherapy vs Atezolizumab + Chemotherapy · Cochran-Mantel-Haenszel · p = 0.8679 · Difference in orr: 0.18 · 95% CI -9.41 to 9.77
SecondaryDoR for Confirmed Responders (C-DoR) in C-DoR-evaluable Population Subset of PD-L1-positive Population

C-DoR was defined as the time from the first occurrence of a documented confirmed response (CR or PR) until the date of PD as determined by the investigator from tumor assessments using RECIST v1.1 or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.

Time frame:
Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months)
Reported as:
Median · months
DoR for Confirmed Responders (C-DoR) in C-DoR-evaluable Population Subset of PD-L1-positive Population
monthsPlacebo + ChemotherapyAtezolizumab + Chemotherapy
DoR for Confirmed Responders (C-DoR) in C-DoR-evaluable Population Subset of PD-L1-positive Population5.78 (4.21 to 8.48)7.92 (6.60 to 12.78)
Statistical analysis
  • Placebo + Chemotherapy vs Atezolizumab + Chemotherapy · Log Rank · p = 0.2846 · Hazard ratio (hr): 0.76 · 95% CI 0.46 to 1.26
SecondaryC-DoR in C-DoR-evaluable Population Subset of mITT Population

C-DoR was defined as the time from the first occurrence of a documented confirmed response (CR or PR) until the date of PD as determined by the investigator from tumor assessments using RECIST v1.1 or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.

Time frame:
Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months)
Reported as:
Median · months
C-DoR in C-DoR-evaluable Population Subset of mITT Population
monthsPlacebo + ChemotherapyAtezolizumab + Chemotherapy
C-DoR in C-DoR-evaluable Population Subset of mITT Population6.51 (4.83 to 8.48)7.43 (5.55 to 12.98)
Statistical analysis
  • Placebo + Chemotherapy vs Atezolizumab + Chemotherapy · Log Rank · p = 0.9853 · Hazard ratio (hr): 1.00 · 95% CI 0.61 to 1.61
SecondaryTime to Confirmed Deterioration (TTD) in Global Health Status/Quality of Life (GHS/QoL) According to the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) in PD-L1-positive Population

TTD in GHS/QoL, defined by a minimally important decrease of ≥10 points at 2 consecutive assessment time-points on the GHS/QoL scale (Items 29, 30) of EORTC QLQ-C30, which consists of 30 questions that assess 5 aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, \& six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Participant responses to questions regarding GHS (Question 29: GHS; "How would you rate your overall health during the past week?") \& QoL (Question 30: QoL; "How would you rate your overall quality of life during the past week?") were assessed \& were scored on a 7-point scale (1= Very poor; 7=Excellent). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating better QoL.

Time frame:
Up to 68 months
Reported as:
Median · months
Time to Confirmed Deterioration (TTD) in Global Health Status/Quality of Life (GHS/QoL) According to the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) in PD-L1-positive Population
monthsPlacebo + ChemotherapyAtezolizumab + Chemotherapy
Time to Confirmed Deterioration (TTD) in Global Health Status/Quality of Life (GHS/QoL) According to the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) in PD-L1-positive Population6.77 (4.30 to 32.69)9.43 (6.01 to NA)
Statistical analysis
  • Placebo + Chemotherapy vs Atezolizumab + Chemotherapy · Log Rank · p = 0.4117 · Hazard ratio (hr): 0.87 · 95% CI 0.63 to 1.21
SecondaryTTD in GHS/QoL According to EORTC QLQ-C30 in mITT Population

TTD in GHS/QoL, defined by a minimally important decrease of ≥10 points at 2 consecutive assessment time-points on the GHS/QoL scale (Items 29, 30) of EORTC QLQ-C30, which consists of 30 questions that assess 5 aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, \& six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Participant responses to questions regarding GHS (Question 29: GHS; "How would you rate your overall health during the past week?") \& QoL (Question 30: QoL; "How would you rate your overall quality of life during the past week?") were assessed \& were scored on a 7-point scale (1= Very poor; 7=Excellent). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating better QoL.

Time frame:
Up to 68 months
Reported as:
Median · months
TTD in GHS/QoL According to EORTC QLQ-C30 in mITT Population
monthsPlacebo + ChemotherapyAtezolizumab + Chemotherapy
TTD in GHS/QoL According to EORTC QLQ-C30 in mITT Population7.66 (4.34 to 32.69)8.90 (5.88 to 16.82)
Statistical analysis
  • Placebo + Chemotherapy vs Atezolizumab + Chemotherapy · Log Rank · p = 0.7215 · Hazard ratio (hr): 0.94 · 95% CI 0.68 to 1.30
SecondaryNumber of Participants With Adverse Events (AEs)

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions that worsen during a study are also considered AEs.

Time frame:
From treatment initiation up to 90 days after last dose (up to 71 months)
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events (AEs)
ParticipantsPlacebo + ChemotherapyAtezolizumab + Chemotherapy
Number of Participants With Adverse Events (AEs)283281
SecondarySerum Concentration of Atezolizumab
Time frame:
Pre-dose on Day 1 of Cycles 1, 2, 3 and 4; Post-dose on Day 1 of Cycles 1 and 3 and Treatment Discontinuation Visit (up to 69 months) (1 Cycle= 3 weeks)
Reported as:
Geometric mean · micrograms/millilitre (µg/mL)
Serum Concentration of Atezolizumab
micrograms/millilitre (µg/mL)Atezolizumab + Chemotherapy
Cycle 1 Day 1 PredoseNA ± NA
Cycle 1 Day 1 Post-dose442 ± 59.7
Cycle 2 Day 1 Pre-dose87.2 ± 72.7
Cycle 3 Day 1 Predose140 ± 42.9
Cycle 3 Day 1 Postdose517 ± 47.7
Cycle 4 Day 1 Predose157 ± 104.9
Treatment Discontinuation120 ± 189.7
SecondaryNumber of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab

Number of ADA-positive participants after drug administration was determined for participants exposed to atezolizumab. For determining post-baseline incidence, participants were considered to be ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following study drug exposure, or if they were ADA-positive at baseline and the titer of 1 or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the baseline titer result. The sum of participants who were ADA-positive at postbaseline visits of Cycles 1 to 4 and treatment discontinuation has been reported here.

Time frame:
Cycles 1 to 4 and Treatment Discontinuation visit (up to 69 months)
Reported as:
Count of participants · Participants
Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
ParticipantsAtezolizumab + Chemotherapy
Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab20
SecondaryNumber of Participants With PD-L1 Protein Expression in Screening Tumour Tissue and Post-baseline Assessment
Time frame:
Baseline up to 68 months
Reported as:
Count of participants · Participants
Number of Participants With PD-L1 Protein Expression in Screening Tumour Tissue and Post-baseline Assessment
ParticipantsPlacebo + ChemotherapyAtezolizumab + Chemotherapy
Baseline IC0- Post-baseline IC 030
Baseline IC1/2/3- Post-baseline IC 000
Baseline IC0- Post-baseline IC1/2/300
Baseline IC1/2/3- Post-baseline IC1/2/362
Other pre-specifiedOS in China Population

OS was defined as time from randomization to death from any cause.

Time frame:
Time from randomization to death (Up to 68 months)

No measurements were reported for this outcome.

Other pre-specified12-month Survival Rate in China Population

12-month survival rate was defined as the percentage of participants alive 12 months after randomization.

Time frame:
12 months

No measurements were reported for this outcome.

Other pre-specified18-month Survival Rate in China Population

18-month survival rate was defined as the percentage of participants alive 18 months after randomization.

Time frame:
18 months

No measurements were reported for this outcome.

Other pre-specifiedPFS in China Population

PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST 1.1, or death from any cause, whichever occurs first.

Time frame:
Time from randomization to the first occurrence of PD or death (Up to 68 months)

No measurements were reported for this outcome.

Other pre-specifiedORR in China Population

ORR was defined as percentage of participants with measurable disease at baseline who achieved a documented unconfirmed OR. OR was defined as either a CR or PR, as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR.

Time frame:
Baseline up to end of study (Up to 68 months)

No measurements were reported for this outcome.

Other pre-specifiedDoR in China Population

DoR was defined as the time from the first occurrence of a documented unconfirmed response (CR or PR) until the date of PD as determined by the investigator from tumor assessments using RECIST v1.1 or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.

Time frame:
Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months)

No measurements were reported for this outcome.

Other pre-specifiedCBR in China Population

CBR was defined as the percentage of participants with either an unconfirmed CR or PR or SD that lasts at least 6 months as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm.

Time frame:
Up to 68 months

No measurements were reported for this outcome.

Other pre-specifiedC-ORR in China Population

C-ORR was defined as percentage of participants with measurable disease at baseline who achieved a documented confirmed OR. OR was defined as either a CR or PR, as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR.

Time frame:
Up to 68 months

No measurements were reported for this outcome.

Other pre-specifiedC-DoR in China Population

C-DoR was defined as the time from the first occurrence of a documented confirmed response (CR or PR) until the date of PD as determined by the investigator from tumor assessments using RECIST v1.1 or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.

Time frame:
Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months)

No measurements were reported for this outcome.

Other pre-specifiedTTD in GHS/QoL According to EORTC QLQ-C30 in China Population

TTD in GHS/QoL, defined by a minimally important decrease of ≥10 points at 2 consecutive assessment time-points on the GHS/QoL scale (Items 29, 30) of EORTC QLQ-C30, which consists of 30 questions that assess 5 aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, \& six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Participant responses to questions regarding GHS (Question 29: GHS; "How would you rate your overall health during the past week?") \& QoL (Question 30: QoL; "How would you rate your overall quality of life during the past week?") were assessed \& were scored on a 7-point scale (1= Very poor; 7=Excellent). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating better QoL.

Time frame:
Up to 68 months

No measurements were reported for this outcome.

Adverse events

Collected over From treatment initiation up to 90 days after the last dose (up to 71 months). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo + Chemotherapy233/294 (79.3%)57/294 (19.4%)278/294 (94.6%)
Atezolizumab + Chemotherapy226/293 (77.1%)69/293 (23.5%)276/293 (94.2%)
Most frequent serious events
Showing 10 of 85
Most frequent serious events
EventPlacebo + ChemotherapyAtezolizumab + Chemotherapy
ThrombocytopeniaBlood and lymphatic system disorders8/2946/293
Platelet count decreasedInvestigations7/2947/293
COVID-19Infections and infestations2/2944/293
PneumoniaInfections and infestations2/2944/293
Pleural effusionRespiratory, thoracic and mediastinal disorders2/2944/293
AnaemiaBlood and lymphatic system disorders4/2943/293
NeutropeniaBlood and lymphatic system disorders2/2943/293
PyrexiaGeneral disorders1/2943/293
DyspnoeaRespiratory, thoracic and mediastinal disorders1/2943/293
Febrile neutropeniaBlood and lymphatic system disorders3/2941/293
Most frequent other events
Showing 10 of 43
Most frequent other events
EventPlacebo + ChemotherapyAtezolizumab + Chemotherapy
AnaemiaBlood and lymphatic system disorders138/294133/293
NauseaGastrointestinal disorders122/294121/293
NeutropeniaBlood and lymphatic system disorders119/294108/293
Alanine aminotransferase increasedInvestigations100/29495/293
Aspartate aminotransferase increasedInvestigations91/29486/293
Neutrophil count decreasedInvestigations88/29477/293
AstheniaGeneral disorders73/29466/293
FatigueGeneral disorders62/29469/293
Platelet count decreasedInvestigations69/29469/293
VomitingGastrointestinal disorders69/29467/293

Baseline characteristics

Full Analysis Set (FAS) population included all participants randomized in the study, grouped according to their assigned treatment arm, whether or not the assigned study treatment was received.

Age, Continuous
Age, Continuous(years)Placebo + ChemotherapyAtezolizumab + ChemotherapyTotal
Mean49.4 ± 11.748.6 ± 10.949.0 ± 11.3
Sex: Female, Male
Sex: Female, Male(Participants)Placebo + ChemotherapyAtezolizumab + ChemotherapyTotal
Female298297595
Male000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Placebo + ChemotherapyAtezolizumab + ChemotherapyTotal
Hispanic or Latino5951110
Not Hispanic or Latino222218440
Unknown or Not Reported172845
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Placebo + ChemotherapyAtezolizumab + ChemotherapyTotal
American Indian or Alaska Native358
Asian6669135
Native Hawaiian or Other Pacific Islander000
Black or African American10919
White199184383
More than one race022
Unknown or Not Reported202848
07

Study locations

124 sites
  • Florida Cancer Specialists - Fort Myers (Broadway)
    Fort Myers, Florida 33916, United States
  • Florida Cancer Specialists & Research Institute
    St. Petersburg, Florida 33705, United States
  • The Valley Hospital
    Paramus, New Jersey 07652, United States
  • Magee-Woman's Hospital
    Pittsburgh, Pennsylvania 15213, United States
  • SCRI Oncology Partners
    Nashville, Tennessee 37203, United States
  • Inova Schar Cancer Institute
    Fairfax, Virginia 22031, United States
  • Hospital Provincial del Centenario
    Rosario, 2000, Argentina
  • Instituto de Oncología de Rosario
    Rosario, S2000KZE, Argentina
  • Clinical center University of Sarajevo
    Sarajevo, 71000, Bosnia and Herzegovina
  • Oncocentro Serviços Medicos E Hospitalares Ltda
    Fortaleza, Ceará 60130-241, Brazil
  • Hospital Araujo Jorge
    Goiânia, Goiás 74605-070, Brazil
  • Hospital do Cancer de Pernambuco - HCP
    Recife, Pernambuco 50040-000, Brazil
  • Hospital Sao Vicente de Paulo
    Passo Fundo, Rio Grande do Sul 99010-090, Brazil
  • Hospital Nossa Senhora da Conceicao
    Porto Alegre, Rio Grande do Sul 91350-200, Brazil
  • Centro de Oncologia de Santa Catarina LTDA
    Chapecó, Santa Catarina 89812-211, Brazil
  • Instituto de Pesquisa Grupo NotreDame Intermedica
    São Paulo, São Paulo 01229-010, Brazil
  • Hospital Perola Byington
    São Paulo, São Paulo 01317-000, Brazil
  • Núcleo de Pesquisa São Camilo
    São Paulo, São Paulo 03102-002, Brazil
  • Bradford Hill Centro de Investigaciones Clinicas
    Recoleta, 8420383, Chile
  • Clinica Vespucio
    Santiago, 8241479, Chile
  • the First Affiliated Hospital of Bengbu Medical College
    Anhui, DUMMY_VALUE, China
  • Cancer Hospital , Chinese Academy of Medical
    Beijing, 100021, China
  • Peking University People's Hospital
    Beijing, 100044, China
  • Beijing Cancer Hospital
    Beijing, 100142, China
  • Jilin Cancer Hospital
    Changchun, 132013, China
  • The First Affiliated Hospital, Chongqing Medical University
    Chongqing, 400016, China
  • Fujian Medical University Union Hospital
    Fujian, 350001, China
  • Sun Yat-sen Memorial Hospital
    Guangzhou, 510000, China
  • Sir Run Run Shaw Hospital Zhejiang University
    Hangzhou, 310016, China
  • Zhejiang Cancer Hospital
    Hangzhou, 310022, China
  • Harbin Medical University Cancer Hospital
    Harbin, 150081, China
  • The First Affiliated Hospital Of Jinzhou Medical University
    Jinzhou, 121001, China
  • Jiangsu Province Hospital
    Nanjing, 210036, China
  • The Affiliated Hospital of Medical College Qingdao University
    Qingdao, 266003, China
  • Fudan University Shanghai Cancer Center
    Shanghai, 200032, China
  • Shanxi Province Cancer Hospital
    Taiyuan, DUMMY_VALUE, China
  • Tianjin Cancer Hospital
    Tianjin, 300060, China
  • The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)
    Xi'an, 710032, China
  • Hospital Hermanos Ameijeiras
    La Habana, 10300, Cuba
  • Instituto Nacional de Oncología y Radiología (INOR)
    La Habana, 10400, Cuba
  • Helsinki University Central Hospital
    Helsinki, 00029, Finland
  • Tampere University Hospital
    Tampere, 33520, Finland
  • Centre Georges-François Lecler
    Dijon, 21034, France
  • Centre Leon Berard
    Lyon, 69373, France
  • Institut Paoli-Calmettes
    Marseille, 13009, France
  • Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque
    Montpellier, 34298, France
  • Centre Eugene Marquis
    Rennes, 35042, France
  • Centre Alexis Vautrin
    Vandœuvre-lès-Nancy, 54511, France
  • IGR
    Villejuif, 94800, France
  • Universitätsklinikum "Carl Gustav Carus"
    Dresden, 01307, Germany
  • Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH
    Essen, 45136, Germany
  • Varisano Klinikum Frankfurt Höchst GmbH
    Frankfurt, 65929, Germany
  • Universitätsklinikum Halle (Saale)
    Halle, 06120, Germany
  • Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe
    Hanover, 30625, Germany
  • Nationales Centrum für Tumorerkrankungen (NCT)
    Heidelberg, 69120, Germany
  • Medizinisches Zentrum für Hämatologie und Onkologie
    München, 80639, Germany
  • Szent Margit Hospital
    Budapest, 1032, Hungary
  • Orszagos Onkologiai Intezet
    Budapest, 1122, Hungary
  • Budapesti Uzsoki Utcai Kórház
    Budapest, 1145, Hungary
  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
    Miskolc, 3526, Hungary
  • Pécsi Tudományegyetem
    Pécs, 7623, Hungary
  • Ospedale Antonio Perrino
    Brindisi, Apulia 72100, Italy
  • Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
    Naples, Campania 80131, Italy
  • Azienda Ospedaliero Universitaria San Martino
    Genoa, Liguria 16132, Italy
  • Ospedale San Raffaele S.r.l.
    Milan, Lombardy 20132, Italy
  • Irccs Istituto Europeo Di Oncologia (IEO)
    Milan, Lombardy 20141, Italy
  • Ospedale San Gerardo
    Monza, Lombardy 20900, Italy
  • Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo
    Candiolo, Piedmont 10060, Italy
  • Azienda Ospedaliero-Universitaria Careggi
    Florence, Tuscany 50134, Italy
  • IRCCS Istituto Oncologico Veneto (IOV)
    Padova, Veneto 35128, Italy
  • Kazakh Scientific Research Institution Of Oncology and Radiology
    Almaty, 050022, Kazakhstan
  • Centro Medico Dalinde
    Mexico City, Mexico CITY (federal District) 06760, Mexico
  • Instituto Nacional de Cancerologia
    Distrito Federal, 14080, Mexico
  • CENEIT Oncologicos
    Mexico City, 03100, Mexico
  • Clinical Center of Montenegro
    Podgorica, 81000, Montenegro
  • Centre Hospitalier Universitaire Hassan II
    Fes, 30000, Morocco
  • Centre Hospitalier Universitaire Mohamed VI
    Marrakesh, 40000, Morocco
  • Clinique specialise Menara
    Marrakesh, 40000, Morocco
  • The Panama Clinic
    Panama City, 32400, Panama
  • Instituto Nacional de Enfermedades Neoplasicas
    Lima, Lima 34, Peru
  • ?wi?tokrzyskie Centrum Onkologii
    Kielce, 25-734, Poland
  • Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad
    Warsaw, 02-781, Poland
  • Hospital de Santa Maria
    Lisbon, 1649-035, Portugal
  • Centro Hospitalar do Porto ? Hospital de Santo António
    Porto, 4099-001, Portugal
  • Moscow City Oncology Hospital #62
    Moscovskaya Oblast, Moscow Oblast 143423, Russia
  • Moscow Clinical Scientific Center
    Moscow, Moscow Oblast 111123, Russia
  • FSBI "National Medical Research Center of Oncology N.N. Blokhin?
    Moscow, Moscow Oblast 115478, Russia
  • Private Healthcare Institution Clinical Hospital RZhD Medicine
    Saint Petersburg, Sankt-Peterburg 195271, Russia
  • City Clinical Oncology Dispensary, SPb SBIH CCOD
    Saint Petersburg, Sankt-Peterburg 198255, Russia
  • FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
    Saint Petersburg, Sankt-Peterburg DUMMY_VALUE, Russia
  • Institute of Oncology and Radiology of Serbia
    Belgrade, 11000, Serbia
  • University Hospital Medical Center Bezanijska kosa
    Belgrade, 11080, Serbia
  • Oncology Institute of Vojvodina
    Kamenitz, 21204, Serbia
  • Clinical Centre Nis, Clinic for Oncology
    Niš, 18000, Serbia
  • National Cancer Centre
    Singapore, 168583, Singapore
  • Wits Clinical Research
    Johannesburg, 2193, South Africa
  • Medical Oncology Centre of Rosebank
    Johannesburg, 2196, South Africa
  • Private Oncology Centre
    Pretoria, 0081, South Africa
  • Seoul National University Bundang Hospital
    Gyeonggi-do, 13620, South Korea
  • Seoul National University Hospital
    Seoul, 03080, South Korea

Showing the first 100 of 124 sites across 28 countries.

08

References and documents

Publications

  • Dent R, Andre F, Goncalves A, Martin M, Schmid P, Schutz F, Kummel S, Swain SM, Bilici A, Loirat D, Villalobos Valencia R, Im SA, Park YH, De Laurentis M, Colleoni M, Guarneri V, Bianchini G, Li H, Kirchmayer Machackova Z, Mouta J, Deurloo R, Gan X, Fan M, Mani A, Swat A, Cortes J. IMpassion132 double-blind randomised phase III trial of chemotherapy with or without atezolizumab for early relapsing unresectable locally advanced or metastatic triple-negative breast cancer. Ann Oncol. 2024 Jul;35(7):630-642. doi: 10.1016/j.annonc.2024.04.001. Epub 2024 May 15. PubMed 38755096 ↗

Study documents

  • Study protocol · Jan 25, 2023
  • Statistical analysis plan · Sep 21, 2022

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03371017
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Dec 13, 2017
Start date
Jan 11, 2018
Primary completion
Oct 23, 2024
Completion
Oct 23, 2024
Results posted
Nov 12, 2025
Last update
Nov 12, 2025

Study contacts

Clinical Trials
study director · Hoffmann-La Roche

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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