A Phase 3 interventional study of Atezolizumab and Paclitaxel in Triple Negative Breast Cancer, sponsored by Hoffmann-La Roche. Terminated at 364 sites in 31 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-21.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
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Among 25 studies testing atezolizumab in Triple Negative Breast Neoplasms — 3 open to participants now, 8 under way, 1 of them phase 3. atezolizumab · Triple Negative Breast Neoplasms.
Among the 25 studies testing atezolizumab in Triple Negative Breast Neoplasms, this one has the largest enrollment, is one of 3 that started in 2018, is one of 9 in phase 3, and was the 13th registered.
1,219 studies on the registry are indexed under Triple Negative Breast Neoplasms; 445 are open to participants now.
Browse Triple Negative Breast Neoplasms studies →3 of the 25 studies testing atezolizumab in Triple Negative Breast Neoplasms are open now, in 3 countries. Recruiting first, the newest first:
European Institute of Oncology · Sites in Italy
Ages 18+
Peter MacCallum Cancer Centre, Australia · Sites in Australia
Ages 18–100
Dana-Farber Cancer Institute · Sites in United States
Ages 18+
By country, each count listing its studies:
atezolizumab: first FDA approval 2016 (TECENTRIQ), first EMA approval 2017. What it is approved for, and how studies give it, is on its page →
Of the 331 Triple Negative Breast Neoplasms studies recruiting now, 231 (70%) set no upper age limit and 85 (26%) stop at 75 or younger; 12 take children under 18; 6 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, atezolizumab is the treatment under test here. Read study by study →
25 studies; the count open now beside each. This study's row is marked.
First in 2015; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 2,199 is above the median of 60 across 1,053 interventional studies indexed under Triple Negative Breast Neoplasms.
Median enrollment 106 across the 25 interventional studies. Of the 16 that completed or were terminated, 12 (75%) have results posted.
This tab as a report to print or save as PDF → With an account.
10 of 25 have an industry lead sponsor. The 10 most frequent:
Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 88 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.
11 studies in Triple Negative Breast Neoplasms by Hoffmann-La Roche: none open now, none under way, none of them phase 3. Of 11 finished, 7 (64%) have results posted.
Among the 11 studies in Triple Negative Breast Neoplasms by Hoffmann-La Roche, this one has the largest enrollment of the 10 interventional ones that give a count, is one of 2 that started in 2018, is one of 7 in phase 3, and was the 8th registered.
Hoffmann-La Roche’s Triple Negative Breast Neoplasms studies by the year they started, since 2015.
3 of the studies testing atezolizumab in Triple Negative Breast Neoplasms that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06690840European Institute of OncologyAtezolizumab and Chemotherapy Treatment as T-cell Activators in Metastatic Triple Negative Breast Cancer Patients | 2026-12-15 |
| NCT04434040Dana-Farber Cancer InstituteAtezolizumab + Sacituzumab Govitecan to Prevent Recurrence in TNBC (ASPRIA) | 2026-12-30 |
| NCT03756298National Cancer Center, KoreaEfficacy and Safety of Atezolizumab Plus Capecitabine Adjuvant Therapy for Triple Receptor-Negative Breast Cancer | 2026-12-31 |
Add all 3 to your calendar (.ics) → With an account.
Among the 25 studies testing atezolizumab in Triple Negative Breast Neoplasms, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Hoffmann-La Roche’s 11 in Triple Negative Breast Neoplasms:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or epirubicin (investigator's choice), and cyclophosphamide, compared with paclitaxel followed by dose-dense doxorubicin or epirubicin (investigator's choice) and cyclophosphamide alone in patients with Stage II-III TNBC (Triple Negative Breast Cancer)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
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.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
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 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.
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.
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.
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.
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.
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.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
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.
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.
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 (in combination with chemotherapy as described below) every 2 weeks for 10 doses, followed by atezolizumab maintenance therapy every 3 weeks to complete 1 year of treatment from the first dose Chemotherapy will consist of paclitaxel every week for 12 weeks, followed by dose-dense doxorubicin +cyclophosphamide or dose-dense epirubicin + cyclophosphamide every 2 weeks, for 4 doses supported with Granulocyte Colony-Stimulating Factor (G-CSF) or Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)
Drug: Atezolizumab · Drug: Paclitaxel · Drug: Dose-dense Doxorubicin or dose-dense Epirubicin · Drug: Cyclophosphamide
Chemotherapy will consist of paclitaxel every week for 12 weeks, followed by dose-dense doxorubicin +cyclophosphamide or dose-dense epirubicin + cyclophosphamide every 2 weeks, for 4 doses supported with Granulocyte Colony-Stimulating Factor (G-CSF) or Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)
Drug: Paclitaxel · Drug: Dose-dense Doxorubicin or dose-dense Epirubicin · Drug: Cyclophosphamide
Atezolizumab will be administered by IV, 840 mg every 2 weeks, for 10 doses. Atezolizumab maintenance will be administered by IV, 1200 mg every 3 weeks to complete 1 year
Paclitaxel will be administered by IV, 80 mg/m\^2 every week for 12 weeks.
Dose-dense doxorubicin will be administered by IV, 60 mg/m\^2 every 2 weeks for a total of 4 doses. Or Dose-dense epirubicin will be administered by IV, (90 mg/m\^2) every 2 weeks for a total of 4 doses
Cyclophosphamide will be administered by IV, 600 mg/m\^2 every 2 weeks for 4 doses
Invasive Disease-Free Survival (iDFS)
iDFS was defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in the axilla, regional lymph nodes, chest wall, \&/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer; Contralateral invasive breast cancer; Distant recurrence (evidence of breast cancer in any anatomic site \[other than the sites mentioned\]) that has either been histologically confirmed \&/or clinically/radiographically diagnosed as recurrent invasive breast cancer; \& Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.
Time frame: From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years)
Invasive Disease-Free Survival (iDFS) in the Subpopulation With Programmed Death-ligand 1 (PD-L1) Selected Tumor Status (IC1/2/3)
iDFS = the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer, Contralateral invasive breast cancer, Distant recurrence (i.e., evidence of breast cancer in any anatomic site \[other than the sites mentioned\]) that has either been histologically confirmed and/or clinically/radiographically diagnosed as recurrent invasive breast cancer and Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.
Time frame: From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years)
Invasive Disease-Free Survival (iDFS) in the Node Positive Subpopulation
iDFS = the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer; Contralateral invasive breast cancer; Distant recurrence (evidence of breast cancer in any anatomic site \[other than the sites mentioned\]) that has either been histologically confirmed and/or clinically/radiographically diagnosed as recurrent invasive breast cancer; and Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.
Time frame: From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years)
Overall Survival (OS)
Overall Survival (OS) is defined as the time from randomization to the date of death due to any cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.
Time frame: From randomization up to death from any cause (up to 5 years)
Invasive Disease-Free Survival (iDFS) Including Second Primary Non-Breast Invasive Cancer
iDFS = the time from randomization until the date of first occurrence of one of the events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in axilla, regional lymph nodes, chest wall, \&/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer; Second primary non-breast invasive cancer; Contralateral invasive breast cancer; Distant recurrence (i.e., evidence of breast cancer in any anatomic site \[other than sites mentioned\]) that has either been histologically confirmed \&/or clinically/radiographically diagnosed as recurrent invasive breast cancer; Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.
Time frame: From randomization up to death from any cause (up to 5 years)
Recurrence-Free Interval (RFI)
Recurrence-Free Interval (RFI) was defined as the time from randomization to the first occurrence of any recurrence (local, regional \[including invasive ipsilateral tumor and invasive locoregional tumor\], or distant), as determined by investigators. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis, participants with no events who died, or participants with no post-baseline information were censored.
Time frame: From randomization up to 5 years
Distant Recurrence-Free Interval (DRFI)
Distant Recurrence-Free Interval (DRFI) was defined as the time from randomization to the distant breast cancer recurrence. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis, participants with no events who died, or participants with no post-baseline information were censored.
Time frame: From randomization up to 5 years
Disease-Free Survival (DFS)
Disease-Free Survival (DFS) was defined as the time from randomization to the first occurrence of disease recurrence or death from any cause. DFS events include: Ipsilateral invasive breast tumor recurrence; Ipsilateral local-regional invasive breast cancer recurrence; Distant recurrence that has either been histologically confirmed or clinically diagnosed as recurrent invasive breast cancer; Contralateral invasive breast cancer; Ipsilateral or contralateral DCIS; Second primary non-breast invasive cancer; Death attributable to any cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.
Time frame: From randomization up to first disease recurrence or death from any cause (up to 5 years)
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Patient-reported Function (Role Functioning [Q6, Q7])
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. For the role functioning scale, participant responses to the 2 questions "Q6: Were you limited in doing either your work or daily activities" and "Q7: Were you limited in pursuing your hobbies or other leisure time activities" were scored on a 4-point scale (1=Not at All to 4=Very Much). The scores were linearly transformed on a scale of 0 to 100, with a low score indicating better functioning. Negative change from baseline indicated improvement.
Time frame: Baseline (Cycle 1 Day 1), Day 1 of Cycles 4, 6, 8, 10, 12, 14 & 16; end of treatment/discontinuation (approximately at Day 351); Follow up: Months 3 to 48 (Total duration is up to 5 years); Cycles 1-5= 28 day cycles; Cycles 6-16: 21 day cycles
Change From Baseline in EORTC QLQ-C30 Patient-reported Function (Physical Functioning [Q1-Q5])
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. For the physical functioning scale, participant responses to 5 questions about daily activities (strenuous activities, long walks, short walks, bed/chair rest \& needing help with eating, dressing, washing themselves, or using the toilet) were scored on a 4-point scale (1=Not at All to 4=Very Much). The scores were linearly transformed on a scale of 0 to 100, with a high score indicating worst functioning. Negative change from baseline indicated improvement in functioning.
Time frame: Baseline (Cycle 1 Day 1), Day 1 of Cycles 4, 6, 8, 10, 12, 14 & 16; end of treatment/discontinuation (approximately at Day 351); Follow up: Months 3 to 48 (Total duration is up to 5 years); Cycles 1-5= 28 day cycles; Cycles 6-16: 21 day cycles
Change From Baseline in EORTC QLQ-C30 Global Health Status (GHS) [Q29] and Health-Related Quality of Life (HRQoL) [Q30] Combined Score
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to the questions regarding Global Health Status (Q29:GHS; "How would you rate your overall health during the past week?") and Quality of Life (Q30: QoL; "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better outcome. Negative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement.
Time frame: Baseline (Cycle 1 Day 1), Day 1 of Cycles 4, 6, 8, 10, 12, 14 & 16; end of treatment/discontinuation (approximately 351 days); Follow up: Months 3 to 48 (Total duration is up to 5 years); Cycles 1-5= 28 day cycles; Cycles 6-16: 21 day cycles
Number of Participants With Adverse Events (AE)
An Adverse Event (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 which worsen during a study are also considered as adverse events. AEs are reported based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0.
Time frame: Up to 5 years
Serum Concentration of Atezolizumab
Time frame: Postdose Day 1 of Cycle 1; Predose Day 1 of Cycles 2, 3, and 4; Predose Cycles 6, 10, and 14; Predose Day 2 of Cycle 16; Cycles 1-5= 28-day cycles; Cycles 6-16: 21-day cycles
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
Baseline evaluable participant= participant with an ADA assay result from a baseline sample(s). Post-baseline evaluable participant= participant with an ADA assay result from at least one postbaseline sample.
Time frame: Up to 5 years
Participants with newly diagnosed Stage II-III primary invasive Breast cancer (BC) that is of triple negative phenotype and who were to be treated with adjuvant systemic chemotherapy following definitive surgery, were enrolled in 342 centers in 31 countries.
| Milestone | Chemotherapy | Atezolizumab and Chemotherapy |
|---|---|---|
| Started | 1098 | 1101 |
| Safety evaluable population | 1084 | 1093 |
| Completed | 0 | 0 |
| Not completed | 1098 | 1101 |
| Withdrew: Withdrawal by subject | 88 | 73 |
| Withdrew: Study terminated by sponsor | 933 | 927 |
| Withdrew: Lost to follow-up | 15 | 26 |
| Withdrew: Disease relapse | 0 | 1 |
| Withdrew: Death | 58 | 72 |
| Withdrew: Physician decision | 4 | 2 |
iDFS was defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in the axilla, regional lymph nodes, chest wall, \&/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer; Contralateral invasive breast cancer; Distant recurrence (evidence of breast cancer in any anatomic site \[other than the sites mentioned\]) that has either been histologically confirmed \&/or clinically/radiographically diagnosed as recurrent invasive breast cancer; \& Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.
| months | Chemotherapy | Atezolizumab and Chemotherapy |
|---|---|---|
| Invasive Disease-Free Survival (iDFS) | NA (NA to NA) | NA (NA to NA) |
iDFS = the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer, Contralateral invasive breast cancer, Distant recurrence (i.e., evidence of breast cancer in any anatomic site \[other than the sites mentioned\]) that has either been histologically confirmed and/or clinically/radiographically diagnosed as recurrent invasive breast cancer and Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.
| months | Chemotherapy | Atezolizumab and Chemotherapy |
|---|---|---|
| Invasive Disease-Free Survival (iDFS) in the Subpopulation With Programmed Death-ligand 1 (PD-L1) Selected Tumor Status (IC1/2/3) | NA (NA to NA) | NA (NA to NA) |
iDFS = the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer; Contralateral invasive breast cancer; Distant recurrence (evidence of breast cancer in any anatomic site \[other than the sites mentioned\]) that has either been histologically confirmed and/or clinically/radiographically diagnosed as recurrent invasive breast cancer; and Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.
| months | Chemotherapy | Atezolizumab and Chemotherapy |
|---|---|---|
| Invasive Disease-Free Survival (iDFS) in the Node Positive Subpopulation | NA (NA to NA) | NA (NA to NA) |
Overall Survival (OS) is defined as the time from randomization to the date of death due to any cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.
| months | Chemotherapy | Atezolizumab and Chemotherapy |
|---|---|---|
| Overall Survival (OS) | NA (NA to NA) | NA (NA to NA) |
iDFS = the time from randomization until the date of first occurrence of one of the events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in axilla, regional lymph nodes, chest wall, \&/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer; Second primary non-breast invasive cancer; Contralateral invasive breast cancer; Distant recurrence (i.e., evidence of breast cancer in any anatomic site \[other than sites mentioned\]) that has either been histologically confirmed \&/or clinically/radiographically diagnosed as recurrent invasive breast cancer; Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.
| months | Chemotherapy | Atezolizumab and Chemotherapy |
|---|---|---|
| Invasive Disease-Free Survival (iDFS) Including Second Primary Non-Breast Invasive Cancer | NA (NA to NA) | NA (NA to NA) |
Recurrence-Free Interval (RFI) was defined as the time from randomization to the first occurrence of any recurrence (local, regional \[including invasive ipsilateral tumor and invasive locoregional tumor\], or distant), as determined by investigators. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis, participants with no events who died, or participants with no post-baseline information were censored.
| months | Chemotherapy | Atezolizumab and Chemotherapy |
|---|---|---|
| Recurrence-Free Interval (RFI) | NA (NA to NA) | NA (NA to NA) |
Distant Recurrence-Free Interval (DRFI) was defined as the time from randomization to the distant breast cancer recurrence. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis, participants with no events who died, or participants with no post-baseline information were censored.
| months | Chemotherapy | Atezolizumab and Chemotherapy |
|---|---|---|
| Distant Recurrence-Free Interval (DRFI) | NA (NA to NA) | NA (NA to NA) |
Disease-Free Survival (DFS) was defined as the time from randomization to the first occurrence of disease recurrence or death from any cause. DFS events include: Ipsilateral invasive breast tumor recurrence; Ipsilateral local-regional invasive breast cancer recurrence; Distant recurrence that has either been histologically confirmed or clinically diagnosed as recurrent invasive breast cancer; Contralateral invasive breast cancer; Ipsilateral or contralateral DCIS; Second primary non-breast invasive cancer; Death attributable to any cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.
| months | Chemotherapy | Atezolizumab and Chemotherapy |
|---|---|---|
| Disease-Free Survival (DFS) | NA (NA to NA) | NA (NA to NA) |
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. For the role functioning scale, participant responses to the 2 questions "Q6: Were you limited in doing either your work or daily activities" and "Q7: Were you limited in pursuing your hobbies or other leisure time activities" were scored on a 4-point scale (1=Not at All to 4=Very Much). The scores were linearly transformed on a scale of 0 to 100, with a low score indicating better functioning. Negative change from baseline indicated improvement.
| score on scale | Chemotherapy | Atezolizumab and Chemotherapy |
|---|---|---|
| Baseline | 87.26 ± 18.92 | 86.43 ± 19.66 |
| CFB: Cycle 4 Day 1 | -10.88 ± 25.00 | -10.26 ± 24.87 |
| CFB: Cycle 6 Day 1 | -17.31 ± 29.94 | -16.56 ± 29.18 |
| CFB: Cycle 8 Day 1 | -4.58 ± 23.58 | -4.58 ± 24.31 |
| CFB: Cycle 10 Day 1 | -3.77 ± 23.59 | -3.43 ± 22.77 |
| CFB: Cycle 12 Day 1 | -1.53 ± 22.39 | -1.59 ± 23.05 |
| CFB: Cycle 14 Day 1 | -1.02 ± 21.69 | -0.70 ± 20.61 |
| CFB: Cycle 16 Day 1 | -1.09 ± 23.16 | -0.10 ± 21.77 |
| CFB: Study Drug Completion/Early Discontinuation | -2.66 ± 23.48 | -4.37 ± 26.12 |
| CFB: Follow-up Month 3 | -0.26 ± 22.62 | -0.40 ± 23.34 |
| CFB: Follow-up Month 6 | 0.20 ± 24.08 | 0.02 ± 24.03 |
| CFB: Follow-up Month 9 | -0.18 ± 23.52 | 0.47 ± 23.35 |
| CFB: Follow-up Month 12 | 0.32 ± 22.42 | 1.22 ± 21.95 |
| CFB: Follow-up Month 18 | -0.47 ± 24.41 | 1.52 ± 21.82 |
| CFB: Follow-up Month 24 | 0.67 ± 23.54 | 1.74 ± 22.28 |
| CFB: Follow-up Month 30 | 2.24 ± 23.36 | 2.01 ± 24.19 |
| CFB: Follow-up Month 36 | 3.08 ± 23.57 | 4.74 ± 20.36 |
| CFB: Follow-up Month 48 | 0.00 ± NA | 13.33 ± 13.94 |
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. For the physical functioning scale, participant responses to 5 questions about daily activities (strenuous activities, long walks, short walks, bed/chair rest \& needing help with eating, dressing, washing themselves, or using the toilet) were scored on a 4-point scale (1=Not at All to 4=Very Much). The scores were linearly transformed on a scale of 0 to 100, with a high score indicating worst functioning. Negative change from baseline indicated improvement in functioning.
| score on scale | Chemotherapy | Atezolizumab and Chemotherapy |
|---|---|---|
| Baseline | 89.86 ± 12.14 | 89.92 ± 11.57 |
| CFB: Cycle 4 Day 1 | -8.93 ± 14.97 | -8.69 ± 14.91 |
| CFB: Cycle 6 Day 1 | -13.30 ± 18.63 | -13.55 ± 18.47 |
| CFB: Cycle 8 Day 1 | -5.33 ± 13.79 | -6.42 ± 14.41 |
| CFB: Cycle 10 Day 1 | -3.71 ± 13.28 | -4.42 ± 13.15 |
| CFB: Cycle 12 Day 1 | -2.41 ± 12.87 | -3.42 ± 12.95 |
| CFB: Cycle 14 Day 1 | -1.41 ± 12.87 | -1.92 ± 12.11 |
| CFB: Cycle 16 Day 1 | -1.65 ± 12.78 | -1.82 ± 12.12 |
| CFB:Study Drug Completion/Early Discontinuation | -2.56 ± 13.72 | -4.68 ± 16.69 |
| CFB:Follow-up Month 3 | -1.62 ± 12.71 | -2.29 ± 13.47 |
| CFB: Follow-up Month 6 | -1.70 ± 13.46 | -1.96 ± 13.78 |
| CFB: Follow-up Month 9 | -1.55 ± 13.75 | -1.33 ± 13.91 |
| CFB: Follow-up Month 12 | -1.70 ± 13.85 | -1.37 ± 13.39 |
| CFB: Follow-up Month 18 | -1.92 ± 13.60 | -0.91 ± 13.79 |
| CFB: Follow-up Month 24 | -1.37 ± 13.89 | -0.72 ± 12.91 |
| CFB: Follow-up Month 30 | -1.61 ± 15.61 | -0.74 ± 12.72 |
| CFB: Follow-up Month 36 | -0.42 ± 14.40 | 0.82 ± 13.18 |
| CFB: Follow-up Month 48 | -13.33 ± NA | -2.67 ± 3.65 |
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to the questions regarding Global Health Status (Q29:GHS; "How would you rate your overall health during the past week?") and Quality of Life (Q30: QoL; "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better outcome. Negative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement.
| score on scale | Chemotherapy | Atezolizumab and Chemotherapy |
|---|---|---|
| Baseline | 76.26 ± 18.15 | 75.90 ± 18.52 |
| CFB: Cycle 4 Day 1 | -10.49 ± 20.25 | -10.02 ± 19.48 |
| CFB: Cycle 6 Day 1 | -15.87 ± 23.83 | -15.68 ± 22.32 |
| CFB: Cycle 8 Day 1 | -3.54 ± 19.72 | -5.09 ± 18.88 |
| CFB: Cycle 10 Day 1 | -1.84 ± 19.57 | -2.82 ± 18.38 |
| CFB: Cycle 12 Day 1 | -0.71 ± 19.41 | -2.31 ± 18.91 |
| CFB: Cycle 14 Day 1 | -0.37 ± 19.04 | -1.25 ± 18.35 |
| CFB: Cycle 16 Day 1 | 0.08 ± 18.56 | -1.30 ± 18.34 |
| CFB:Study Drug Completion/Early Discontinuation | -1.56 ± 20.68 | -4.39 ± 22.01 |
| CFB: Follow-up Month 3 | 1.01 ± 20.25 | -0.74 ± 20.50 |
| CFB: Follow-up Month 6 | 1.10 ± 20.23 | -0.90 ± 20.72 |
| CFB: Follow-up Month 9 | 0.62 ± 20.47 | 0.07 ± 20.83 |
| CFB: Follow-up Month 12 | 1.21 ± 20.42 | 0.19 ± 19.84 |
| CFB: Follow-up Month 18 | 1.09 ± 22.18 | 0.47 ± 20.77 |
| CFB: Follow-up Month 24 | 2.32 ± 22.30 | 0.43 ± 21.33 |
| CFB: Follow-up Month 30 | 1.54 ± 21.36 | -0.57 ± 22.43 |
| CFB: Follow-up Month 36 | 2.64 ± 20.95 | 0.58 ± 23.57 |
| CFB: Follow-up Month 48 | 0.00 ± NA | 6.25 ± 31.46 |
An Adverse Event (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 which worsen during a study are also considered as adverse events. AEs are reported based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0.
| Participants | Chemotherapy | Atezolizumab and Chemotherapy |
|---|---|---|
| Number of Participants With Adverse Events (AE) | 1074 | 1090 |
| microgram per milliliter (µg/mL) | Atezolizumab and Chemotherapy |
|---|---|
| Post-dose: Cycle 1 Day 1 | 319 ± 43.3 |
| Pre-dose: Cycle 2 Day 1 | 153 ± 85.2 |
| Pre-dose: Cycle 3 Day 1 | 220 ± 62.0 |
| Pre-dose: Cycle 4 Day 1 | 221 ± 120.4 |
| Pre-dose: Cycle 6 | 239 ± 146.9 |
| Pre-dose: Cycle 10 | 250 ± 92.2 |
| Pre-dose: Cycle 14 | 258 ± 118.7 |
| Pre-dose: Cycle 16 Day 2 | 355 ± 29.5 |
Baseline evaluable participant= participant with an ADA assay result from a baseline sample(s). Post-baseline evaluable participant= participant with an ADA assay result from at least one postbaseline sample.
| percentage of participants | Atezolizumab and Chemotherapy |
|---|---|
| Baseline | 2.1 |
| Post-baseline | 11.5 |
Collected over Up to 5 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Chemotherapy | 58/1,098 (5.3%) | 173/1,084 (16%) | 1,068/1,084 (98.5%) |
| Atezolizumab and Chemotherapy | 72/1,101 (6.5%) | 280/1,093 (25.6%) | 1,082/1,093 (99%) |
| Event | Chemotherapy | Atezolizumab and Chemotherapy |
|---|---|---|
| NeutropeniaBlood and lymphatic system disorders | 31/1084 | 40/1093 |
| Febrile neutropeniaBlood and lymphatic system disorders | 23/1084 | 29/1093 |
| LeukopeniaBlood and lymphatic system disorders | 5/1084 | 18/1093 |
| PneumoniaInfections and infestations | 17/1084 | 18/1093 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 4/1084 | 18/1093 |
| Neutrophil count decreasedInvestigations | 14/1084 | 11/1093 |
| PyrexiaGeneral disorders | 10/1084 | 13/1093 |
| White blood cell count decreasedInvestigations | 6/1084 | 10/1093 |
| COVID-19Infections and infestations | 7/1084 | 9/1093 |
| Lymphocyte count decreasedInvestigations | 0/1084 | 7/1093 |
| Event | Chemotherapy | Atezolizumab and Chemotherapy |
|---|---|---|
| AlopeciaSkin and subcutaneous tissue disorders | 715/1084 | 735/1093 |
| NauseaGastrointestinal disorders | 531/1084 | 553/1093 |
| AnaemiaBlood and lymphatic system disorders | 422/1084 | 420/1093 |
| FatigueGeneral disorders | 268/1084 | 325/1093 |
| Alanine aminotransferase increasedInvestigations | 240/1084 | 296/1093 |
| DiarrhoeaGastrointestinal disorders | 188/1084 | 287/1093 |
| Neutrophil count decreasedInvestigations | 254/1084 | 273/1093 |
| Aspartate aminotransferase increasedInvestigations | 159/1084 | 246/1093 |
| NeutropeniaBlood and lymphatic system disorders | 240/1084 | 236/1093 |
| AstheniaGeneral disorders | 230/1084 | 234/1093 |
Intent-to-Treat (ITT) population included all randomized participants, whether or not the assigned study treatment was received.
| Age, Continuous(years) | Chemotherapy | Atezolizumab and Chemotherapy | Total |
|---|---|---|---|
| Mean | 52.8 ± 11.4 | 52.3 ± 11.9 | 52.5 ± 11.6 |
| Sex: Female, Male(Participants) | Chemotherapy | Atezolizumab and Chemotherapy | Total |
|---|---|---|---|
| Female | 1094 | 1101 | 2195 |
| Male | 4 | 0 | 4 |
| Ethnicity (NIH/OMB)(Participants) | Chemotherapy | Atezolizumab and Chemotherapy | Total |
|---|---|---|---|
| Hispanic or Latino | 100 | 75 | 175 |
| Not Hispanic or Latino | 906 | 950 | 1856 |
| Unknown or Not Reported | 92 | 76 | 168 |
| Race (NIH/OMB)(Participants) | Chemotherapy | Atezolizumab and Chemotherapy | Total |
|---|---|---|---|
| American Indian or Alaska Native | 28 | 29 | 57 |
| Asian | 401 | 423 | 824 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 2 | 8 | 10 |
| White | 567 | 554 | 1121 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 99 | 86 | 185 |
Showing the first 100 of 364 sites across 31 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Aug 2018 to primary completion in Aug 2023, 60 months.
Results were first posted in Aug 2024, 1 year after primary completion.
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Studies of the drug tested here: Atezolizumab
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