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
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).
1,219 studies on the registry are indexed under Triple Negative Breast Neoplasms; 446 are open to participants now.
This study's enrollment of 595 is above the median of 60 across 1,053 interventional studies indexed under Triple Negative Breast Neoplasms.
Browse Triple Negative Breast Neoplasms studies →Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 87 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Inclusion criteria for patients enrolled after the recruitment of all-comers is complete:
--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:
Exclusion Criteria Related to Atezolizumab:
Exclusion Criteria Related to 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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive Atezolizumab on day 1 of each 3-week treatment cycle
Drug: Atezolizumab · Drug: Gemcitabine · Drug: Capecitabine · Drug: Carboplatin
Participants will receive Placebo on day 1 of each 3-week treatment cycle
Drug: Placebo · Drug: Gemcitabine · Drug: Capecitabine · Drug: Carboplatin
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
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
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
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
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
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)
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)
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
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
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
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
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)
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)
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)
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)
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)
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)
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
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
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
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
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)
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)
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
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
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)
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)
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)
Number of Participants With PD-L1 Protein Expression in Screening Tumour Tissue and Post-baseline Assessment
Time frame: Baseline up to 68 months
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)
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
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
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)
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)
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)
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
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
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)
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
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.
| Milestone | Placebo + Chemotherapy | Atezolizumab + Chemotherapy |
|---|---|---|
| Started | 298 | 297 |
| Safety-evaluable population | 294 | 293 |
| Programmed death-ligand 1 (pd-l1)-positive population | 177 | 177 |
| Modified intent-to-treat (mitt) population | 192 | 188 |
| Completed | 0 | 0 |
| Not completed | 298 | 297 |
| Withdrew: Physician decision | 0 | 1 |
| Withdrew: Reason not specified | 0 | 1 |
| Withdrew: Lost to follow-up | 13 | 16 |
| Withdrew: Death | 228 | 215 |
| Withdrew: Withdrawal by subject | 20 | 25 |
| Withdrew: Study ended by sponsor | 37 | 38 |
| Withdrew: Protocol deviation | 0 | 1 |
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.
| months | Placebo + Chemotherapy | Atezolizumab + Chemotherapy |
|---|---|---|
| Overall Survival (OS) in PD-L1-positive Population | 11.24 (9.00 to 13.31) | 12.09 (10.12 to 15.08) |
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.
| months | Placebo + Chemotherapy | Atezolizumab + Chemotherapy |
|---|---|---|
| OS in Modified Intent-to-treat (mITT) Population | 9.79 (8.44 to 11.96) | 10.35 (8.90 to 12.88) |
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.
| percentage of participants | Placebo + Chemotherapy | Atezolizumab + Chemotherapy |
|---|---|---|
| 12-month Survival Rate in PD-L1-positive Population | 47.58 (39.92 to 55.23) | 50.26 (42.61 to 57.91) |
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.
| percentage of participants | Placebo + Chemotherapy | Atezolizumab + Chemotherapy |
|---|---|---|
| 12-month Survival Rate in mITT Population | 42.44 (35.23 to 49.66) | 46.20 (38.84 to 53.56) |
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.
| percentage of participants | Placebo + Chemotherapy | Atezolizumab + Chemotherapy |
|---|---|---|
| 18-month Survival Rate in PD-L1-positive Population | 32.48 (25.07 to 39.89) | 33.63 (26.05 to 41.21) |
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.
| percentage of participants | Placebo + Chemotherapy | Atezolizumab + Chemotherapy |
|---|---|---|
| 18-month Survival Rate in mITT Population | 25.68 (19.15 to 32.21) | 27.05 (20.39 to 33.71) |
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.
| months | Placebo + Chemotherapy | Atezolizumab + Chemotherapy |
|---|---|---|
| Progression-free Survival (PFS) in PD-L1-positive Population | 3.58 (3.35 to 4.17) | 4.21 (3.71 to 5.62) |
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.
| months | Placebo + Chemotherapy | Atezolizumab + Chemotherapy |
|---|---|---|
| PFS in mITT Population | 3.58 (3.06 to 3.81) | 3.71 (2.83 to 4.01) |
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.
| percentage of participants | Placebo + Chemotherapy | Atezolizumab + Chemotherapy |
|---|---|---|
| Objective Response Rate (ORR) in Response-evaluable Population, Subset of PD-L1-positive Population | 28.3 (21.45 to 35.98) | 39.6 (31.83 to 47.80) |
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.
| percentage of participants | Placebo + Chemotherapy | Atezolizumab + Chemotherapy |
|---|---|---|
| ORR in Response-evaluable Population, Subset of mITT Population | 32.1 (25.16 to 39.77) | 31.0 (24.16 to 38.51) |
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.
| months | Placebo + Chemotherapy | Atezolizumab + Chemotherapy |
|---|---|---|
| Duration of Objective Response (DoR) in DoR-evaluable Population Subset of PD-L1-positive Population | 4.14 (3.45 to 5.78) | 6.60 (4.63 to 8.02) |
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.
| months | Placebo + Chemotherapy | Atezolizumab + Chemotherapy |
|---|---|---|
| DoR in DoR-evaluable Population Subset of mITT Population | 5.22 (3.81 to 6.60) | 5.70 (4.17 to 7.92) |
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.
| percentage of participants | Placebo + Chemotherapy | Atezolizumab + Chemotherapy |
|---|---|---|
| Clinical Benefit Rate (CBR) in Response-evaluable Population Subset of PD-L1-positive Population | 34.6 (27.23 to 42.53) | 42.9 (34.92 to 51.07) |
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.
| percentage of participants | Placebo + Chemotherapy | Atezolizumab + Chemotherapy |
|---|---|---|
| CBR in Response-evaluable Population Subset of mITT Population | 36.3 (29.04 to 44.07) | 35.1 (27.96 to 42.74) |
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.
| percentage of participants | Placebo + Chemotherapy | Atezolizumab + Chemotherapy |
|---|---|---|
| Confirmed Objective Response Rate (C-ORR) in Response-evaluable Population Subset of PD-L1-positive Population | 19.5 (13.65 to 26.52) | 31.2 (23.96 to 39.12) |
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.
| percentage of participants | Placebo + Chemotherapy | Atezolizumab + Chemotherapy |
|---|---|---|
| C-ORR in Response-evaluable Population Subset of mITT Population | 23.2 (17.06 to 30.34) | 23.4 (17.27 to 30.46) |
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.
| months | Placebo + Chemotherapy | Atezolizumab + Chemotherapy |
|---|---|---|
| DoR for Confirmed Responders (C-DoR) in C-DoR-evaluable Population Subset of PD-L1-positive Population | 5.78 (4.21 to 8.48) | 7.92 (6.60 to 12.78) |
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.
| months | Placebo + Chemotherapy | Atezolizumab + Chemotherapy |
|---|---|---|
| C-DoR in C-DoR-evaluable Population Subset of mITT Population | 6.51 (4.83 to 8.48) | 7.43 (5.55 to 12.98) |
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.
| months | Placebo + Chemotherapy | Atezolizumab + 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 Population | 6.77 (4.30 to 32.69) | 9.43 (6.01 to NA) |
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.
| months | Placebo + Chemotherapy | Atezolizumab + Chemotherapy |
|---|---|---|
| TTD in GHS/QoL According to EORTC QLQ-C30 in mITT Population | 7.66 (4.34 to 32.69) | 8.90 (5.88 to 16.82) |
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.
| Participants | Placebo + Chemotherapy | Atezolizumab + Chemotherapy |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | 283 | 281 |
| micrograms/millilitre (µg/mL) | Atezolizumab + Chemotherapy |
|---|---|
| Cycle 1 Day 1 Predose | NA ± NA |
| Cycle 1 Day 1 Post-dose | 442 ± 59.7 |
| Cycle 2 Day 1 Pre-dose | 87.2 ± 72.7 |
| Cycle 3 Day 1 Predose | 140 ± 42.9 |
| Cycle 3 Day 1 Postdose | 517 ± 47.7 |
| Cycle 4 Day 1 Predose | 157 ± 104.9 |
| Treatment Discontinuation | 120 ± 189.7 |
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.
| Participants | Atezolizumab + Chemotherapy |
|---|---|
| Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab | 20 |
| Participants | Placebo + Chemotherapy | Atezolizumab + Chemotherapy |
|---|---|---|
| Baseline IC0- Post-baseline IC 0 | 3 | 0 |
| Baseline IC1/2/3- Post-baseline IC 0 | 0 | 0 |
| Baseline IC0- Post-baseline IC1/2/3 | 0 | 0 |
| Baseline IC1/2/3- Post-baseline IC1/2/3 | 6 | 2 |
OS was defined as time from randomization to death from any cause.
No measurements were reported for this outcome.
12-month survival rate was defined as the percentage of participants alive 12 months after randomization.
No measurements were reported for this outcome.
18-month survival rate was defined as the percentage of participants alive 18 months after randomization.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo + Chemotherapy | 233/294 (79.3%) | 57/294 (19.4%) | 278/294 (94.6%) |
| Atezolizumab + Chemotherapy | 226/293 (77.1%) | 69/293 (23.5%) | 276/293 (94.2%) |
| Event | Placebo + Chemotherapy | Atezolizumab + Chemotherapy |
|---|---|---|
| ThrombocytopeniaBlood and lymphatic system disorders | 8/294 | 6/293 |
| Platelet count decreasedInvestigations | 7/294 | 7/293 |
| COVID-19Infections and infestations | 2/294 | 4/293 |
| PneumoniaInfections and infestations | 2/294 | 4/293 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 2/294 | 4/293 |
| AnaemiaBlood and lymphatic system disorders | 4/294 | 3/293 |
| NeutropeniaBlood and lymphatic system disorders | 2/294 | 3/293 |
| PyrexiaGeneral disorders | 1/294 | 3/293 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/294 | 3/293 |
| Febrile neutropeniaBlood and lymphatic system disorders | 3/294 | 1/293 |
| Event | Placebo + Chemotherapy | Atezolizumab + Chemotherapy |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 138/294 | 133/293 |
| NauseaGastrointestinal disorders | 122/294 | 121/293 |
| NeutropeniaBlood and lymphatic system disorders | 119/294 | 108/293 |
| Alanine aminotransferase increasedInvestigations | 100/294 | 95/293 |
| Aspartate aminotransferase increasedInvestigations | 91/294 | 86/293 |
| Neutrophil count decreasedInvestigations | 88/294 | 77/293 |
| AstheniaGeneral disorders | 73/294 | 66/293 |
| FatigueGeneral disorders | 62/294 | 69/293 |
| Platelet count decreasedInvestigations | 69/294 | 69/293 |
| VomitingGastrointestinal disorders | 69/294 | 67/293 |
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(years) | Placebo + Chemotherapy | Atezolizumab + Chemotherapy | Total |
|---|---|---|---|
| Mean | 49.4 ± 11.7 | 48.6 ± 10.9 | 49.0 ± 11.3 |
| Sex: Female, Male(Participants) | Placebo + Chemotherapy | Atezolizumab + Chemotherapy | Total |
|---|---|---|---|
| Female | 298 | 297 | 595 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Placebo + Chemotherapy | Atezolizumab + Chemotherapy | Total |
|---|---|---|---|
| Hispanic or Latino | 59 | 51 | 110 |
| Not Hispanic or Latino | 222 | 218 | 440 |
| Unknown or Not Reported | 17 | 28 | 45 |
| Race (NIH/OMB)(Participants) | Placebo + Chemotherapy | Atezolizumab + Chemotherapy | Total |
|---|---|---|---|
| American Indian or Alaska Native | 3 | 5 | 8 |
| Asian | 66 | 69 | 135 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 10 | 9 | 19 |
| White | 199 | 184 | 383 |
| More than one race | 0 | 2 | 2 |
| Unknown or Not Reported | 20 | 28 | 48 |
Showing the first 100 of 124 sites across 28 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jan 2018 to primary completion in Oct 2024, 81 months.
Results were first posted in Nov 2025, 1 year after primary completion.
Of 60 phase 3 interventional studies under Triple Negative Breast Neoplasms, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 103. This study's 81 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Atezolizumab
Triple Negative Breast Neoplasms →