Trial · NCT03371017
A Study of the Efficacy and Safety of Atezolizumab Plus Chemotherapy for Patients With Early Relapsing Recurrent Triple-Negative Breast Cancer
NCT03371017, Phase 3, Completed, Hoffmann-La Roche; results first posted 2025-11-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of the Efficacy and Safety of Atezolizumab Plus Chemotherapy for Patients With Early Relapsing Recurrent Triple-Negative Breast Cancer. Trials, record NCT03371017. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03371017
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Efficacy and Safety of Atezolizumab Plus Chemotherapy for Patients With Early Relapsing Recurrent Triple-Negative Breast Cancer
- NCT number
- NCT03371017
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 595 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Triple Negative Breast Neoplasms
- Interventions
- Atezolizumab, Placebo, Gemcitabine, Capecitabine, Carboplatin
- First posted
- 2017-12-13
- Last updated
- 2025-11-12
- Other registries' IDs
- eudract:2016-005119-42
- Results first posted
- 2025-11-12
Source ClinicalTrials.gov
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) in PD-L1-positive Population | Time from randomization to death (Up to 68 months) | 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. |
| Primary | OS in Modified Intent-to-treat (mITT) Population | Time from randomization to death (Up to 68 months) | 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. |
| Secondary | 12-month Survival Rate in PD-L1-positive Population | 12 months | 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. |
| Secondary | 12-month Survival Rate in mITT Population | 12 months | 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. |
| Secondary | 18-month Survival Rate in PD-L1-positive Population | 18 months | 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. |
| Secondary | 18-month Survival Rate in mITT Population | 18 months | 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. |
| Secondary | Progression-free Survival (PFS) in PD-L1-positive Population | Time from randomization to the first occurrence of PD or death (Up to 68 months) | 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. |
| Secondary | PFS in mITT Population | Time from randomization to the first occurrence of PD or death (Up to 68 months) | 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. |
| Secondary | Objective Response Rate (ORR) in Response-evaluable Population, Subset of PD-L1-positive Population | Baseline up to end of study (Up to 68 months) | 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. |
| Secondary | ORR in Response-evaluable Population, Subset of mITT Population | Baseline up to end of study (Up to 68 months) | 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. |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 registered outcomesOutcomes34
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) in PD-L1-positive Population | Time from randomization to death (Up to 68 months) | PD-L1 positive population included all participants randomized in the study whose PD-L1 status was tumor-infiltrating IC of 1% or greater (IC1/2/3) at the time of randomization, grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. | months | MEDIAN |
| PRIMARY | OS in Modified Intent-to-treat (mITT) Population | Time from randomization to death (Up to 68 months) | mITT population included all participants randomized under the protocol versions prior to version 4.0 (referred to as all-comers, i.e., PD-L1(SP142)-positive and PD-L1(SP142)-negative participants, grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. | months | MEDIAN |
| SECONDARY | 12-month Survival Rate in PD-L1-positive Population | 12 months | PD-L1 positive population included all participants randomized in the study whose PD-L1 status was tumor-infiltrating IC of 1% or greater (IC1/2/3) at the time of randomization, grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. | percentage of participants | NUMBER |
| SECONDARY | 12-month Survival Rate in mITT Population | 12 months | mITT population included all participants randomized under the protocol versions prior to version 4.0 (referred to as all-comers, i.e., PD-L1(SP142)-positive and PD-L1(SP142)-negative participants), grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. | percentage of participants | NUMBER |
| SECONDARY | 18-month Survival Rate in PD-L1-positive Population | 18 months | PD-L1 positive population included all participants randomized in the study whose PD-L1 status was tumor-infiltrating IC of 1% or greater (IC1/2/3) at the time of randomization, grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. | percentage of participants | NUMBER |
| SECONDARY | 18-month Survival Rate in mITT Population | 18 months | mITT population included all participants randomized under the protocol versions prior to version 4.0 (referred to as all-comers, i.e., PD-L1(SP142)-positive and PD-L1(SP142)-negative participants), grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) in PD-L1-positive Population | Time from randomization to the first occurrence of PD or death (Up to 68 months) | PD-L1 positive population included all participants randomized in the study whose PD-L1 status was tumor-infiltrating IC of 1% or greater (IC1/2/3) at the time of randomization, grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. | months | MEDIAN |
| SECONDARY | PFS in mITT Population | Time from randomization to the first occurrence of PD or death (Up to 68 months) | mITT population included all participants randomized under the protocol versions prior to version 4.0 (referred to as all-comers, i.e., PD-L1(SP142)-positive and PD-L1(SP142)-negative participants), grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) in Response-evaluable Population, Subset of PD-L1-positive Population | Baseline up to end of study (Up to 68 months) | PD-L1 positive population included all participants randomized in the study whose PD-L1 status was tumor-infiltrating IC of 1% or greater (IC1/2/3) at the time of randomization, grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. Response-evaluable Population included participants randomized in the study with measurable disease at baseline. | percentage of participants | NUMBER |
| SECONDARY | ORR in Response-evaluable Population, Subset of mITT Population | Baseline up to end of study (Up to 68 months) | mITT population included all participants randomized under the protocol versions prior to version 4.0 (referred to as all-comers, i.e., PD-L1 (SP142)-positive and PD-L1 (SP142)-negative participants), grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. Response-evaluable Population included participants randomized in the study with measurable disease at baseline. | percentage of participants | NUMBER |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 outcomesResults by group58
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) in PD-L1-positive Population | Placebo + Chemotherapy | 11.24 | 95% Confidence Interval 9.00 to 13.31 | months | |
| Overall Survival (OS) in PD-L1-positive Population | Atezolizumab + Chemotherapy | 12.09 | 95% Confidence Interval 10.12 to 15.08 | months | |
| OS in Modified Intent-to-treat (mITT) Population | Placebo + Chemotherapy | 9.79 | 95% Confidence Interval 8.44 to 11.96 | months | |
| OS in Modified Intent-to-treat (mITT) Population | Atezolizumab + Chemotherapy | 10.35 | 95% Confidence Interval 8.90 to 12.88 | months | |
| 12-month Survival Rate in PD-L1-positive Population | Placebo + Chemotherapy | 47.58 | 95% Confidence Interval 39.92 to 55.23 | percentage of participants | |
| 12-month Survival Rate in PD-L1-positive Population | Atezolizumab + Chemotherapy | 50.26 | 95% Confidence Interval 42.61 to 57.91 | percentage of participants | |
| 12-month Survival Rate in mITT Population | Placebo + Chemotherapy | 42.44 | 95% Confidence Interval 35.23 to 49.66 | percentage of participants | |
| 12-month Survival Rate in mITT Population | Atezolizumab + Chemotherapy | 46.20 | 95% Confidence Interval 38.84 to 53.56 | percentage of participants | |
| 18-month Survival Rate in PD-L1-positive Population | Placebo + Chemotherapy | 32.48 | 95% Confidence Interval 25.07 to 39.89 | percentage of participants | |
| 18-month Survival Rate in PD-L1-positive Population | Atezolizumab + Chemotherapy | 33.63 | 95% Confidence Interval 26.05 to 41.21 | percentage of participants |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo + Chemotherapy | 298 | |
| Overall Study | STARTED | Atezolizumab + Chemotherapy | 297 | |
| Overall Study | Safety-evaluable Population | Placebo + Chemotherapy | 294 | |
| Overall Study | Safety-evaluable Population | Atezolizumab + Chemotherapy | 293 | |
| Overall Study | Programmed Death-ligand 1 (PD-L1)-Positive Population | Placebo + Chemotherapy | 177 | |
| Overall Study | Programmed Death-ligand 1 (PD-L1)-Positive Population | Atezolizumab + Chemotherapy | 177 | |
| Overall Study | Modified Intent-to-Treat (mITT) Population | Placebo + Chemotherapy | 192 | |
| Overall Study | Modified Intent-to-Treat (mITT) Population | Atezolizumab + Chemotherapy | 188 | |
| Overall Study | COMPLETED | Placebo + Chemotherapy | 0 | |
| Overall Study | COMPLETED | Atezolizumab + Chemotherapy | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events256
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Placebo + Chemotherapy | 138 | 294 | 210 |
| other | Anaemia | Blood and lymphatic system disorders | Atezolizumab + Chemotherapy | 133 | 293 | 199 |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo + Chemotherapy | 42 | 294 | 130 |
| other | Leukopenia | Blood and lymphatic system disorders | Atezolizumab + Chemotherapy | 52 | 293 | 153 |
| other | Lymphopenia | Blood and lymphatic system disorders | Placebo + Chemotherapy | 17 | 294 | 34 |
| other | Lymphopenia | Blood and lymphatic system disorders | Atezolizumab + Chemotherapy | 26 | 293 | 40 |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo + Chemotherapy | 119 | 294 | 322 |
| other | Neutropenia | Blood and lymphatic system disorders | Atezolizumab + Chemotherapy | 108 | 293 | 341 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo + Chemotherapy | 54 | 294 | 123 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Atezolizumab + Chemotherapy | 52 | 293 | 117 |
1 to 10 of 256Source ClinicalTrials.gov
See all 256 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo + Chemotherapy | 233 | 294 |
| Total, all-cause mortality | Atezolizumab + Chemotherapy | 226 | 293 |
| Total, other adverse events | Placebo + Chemotherapy | 278 | 294 |
| Total, other adverse events | Atezolizumab + Chemotherapy | 276 | 293 |
| Total, serious adverse events | Placebo + Chemotherapy | 57 | 294 |
| Total, serious adverse events | Atezolizumab + Chemotherapy | 69 | 293 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38755096 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Placebo + Chemotherapy vs Atezolizumab + Chemotherapy: Number of Participants With Adverse Events (AEs) | Trial comparisons |
| Placebo + Chemotherapy vs Atezolizumab + Chemotherapy: deaths from any cause | Trial comparisons |
| Placebo + Chemotherapy vs Atezolizumab + Chemotherapy: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03371017
GET https://conductscience.org/api/trials/v1/NCT03371017/registered?page=2