Trial · NCT03197935
A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer
NCT03197935, Phase 3, Completed, Hoffmann-La Roche; results first posted 2021-06-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer. Trials, record NCT03197935. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03197935
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer
- NCT number
- NCT03197935
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 333 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Triple-negative Breast Cancer
- Interventions
- Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody, Placebo, Nab-paclitaxel, Doxorubicin, Cyclophosphamide, Filgrastim, Pegfilgrastim
- First posted
- 2017-06-23
- Last updated
- 2023-10-26
- Other registries' IDs
- eudract:2016-004734-22
- Results first posted
- 2021-06-02
- Limitations and caveats
This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoints of EFS, DFS and OS. The analyses of these secondary endpoints are descriptive in nature.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population | After neoadjuvant study treatment and surgery, up to primary analysis data cut off on 03 ApriI 2020 | Number of participants with Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population. pCR is defined as eradication of invasive tumor from both breast and lymph nodes (ypT0/is ypN0). pCR was evaluated for each participant after neoadjuvant study treatment and surgery. Participants whose pCR assessment was missing will be counted as not achieving a pCR. |
| Primary | Number of Participants With pCR in Subpopulation With PD-L1-Positive Tumor Status (Tumor-infiltrating Immune Cell [IC] 1/2/3) Using AJCC Staging System | After neoadjuvant study treatment and surgery, up to primary analysis data cut off on 03 ApriI 2020 | Number of participants with Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in the subpopulation with programmed death-ligand1 (PD-L1)-positive tumor status(tumor-infiltrating immune cell \[IC\] IC1/2/3) . pCR is defined as eradication of invasive tumor from both breast and lymph nodes (ypT0/is ypN0). pCR was evaluated for each participant after neoadjuvant study treatment and surgery. Participants whose pCR assessment was missing will be counted as not achieving a pCR. |
| Secondary | Event-Free Survival (EFS) in All Participants | From randomization and up to study final analysis data cut off on 28 September 2022. | Event-free survival (EFS) defined as the time from randomization to the first documented occurrence of disease recurrence, disease progression, or death from any cause in all participants. Recurrent disease includes local, regional, or distant recurrence and contralateral breast cancer. Ipsilateral or contralateral in situ disease and second primary non-breast cancers (including in situ carcinomas and non-melanoma skin cancers) will not be counted as progressive disease or recurrent disease. |
| Secondary | Event-Free Survival (EFS) in Subpopulation With PD-L1-Postive Tumor Status | From randomization and up to study final analysis data cut off on 28 September 2022. | Event-free survival (EFS) defined as the time from randomization to the first documented occurrence of disease recurrence, disease progression, or death from any cause in the subpopulation with PD-L1-positive tumor status. Recurrent disease includes local, regional, or distant recurrence and contralateral breast cancer. Ipsilateral or contralateral in situ disease and second primary non-breast cancers (including in situ carcinomas and non-melanoma skin cancers) will not be counted as progressive disease or recurrent disease. |
| Secondary | Disease-Free Survival (DFS) in All Participants Who Undergo Surgery | From surgery and up to study final analysis data cut off on 28 September 2022. | Disease-free survival (DFS) defined as the time from surgery to the first documented disease recurrence or death from any cause, whichever occurs first. DFS is analyzed with the use of the same methodology as specified for EFS for all participants. |
| Secondary | Disease-Free Survival (DFS) in Subpopulation of Participants With PD-L1-Positive Tumor Status Who Undergo Surgery | From surgery and up to study final analysis data cut off on 28 September 2022. | Disease-free survival (DFS) defined as the time from surgery to the first documented disease recurrence or death from any cause, whichever occurs first. DFS is analyzed with the use of the same methodology as specified for EFS for the subpopulation of participants with PD-L1-positive tumor status. |
| Secondary | Overall Survival (OS) in All Participants | From randomization and up to study final analysis data cut off on 28 September 2022. | Overall survival (OS) defined as the time from randomization to the date of death from any cause in all participants. |
| Secondary | Overall Survival (OS) in Subpopulation With PD-L1-Positive Tumor Status | From randomization and up to study final analysis data cut off on 28 September 2022. | Overall survival (OS) defined as the time from randomization to the date of death from any cause in the subpopulation with PD-L1-positive tumor status. |
| Secondary | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | From randomization and up to study final analysis data cut off on 28 September 2022. | Mean score in function (role, physical) and global health status(GHS)/ health-related quality of life (HRQoL) by cycle and between treatment arms as assessed by the functional and HRQoL scales of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core30(QLQ C30). The score range for each scale and single-item measure is 0 to 100, where higher scores indicate a higher response level (i.e., better functioning, better QoL, worse symptoms). |
| Secondary | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | From randomization and up to study final analysis data cut off on 28 September 2022. | Mean change from baseline score in function (role, physical) and global health status(GHS)/ health-related quality of life (HRQoL) by cycle and between treatment arms as assessed by the functional and HRQoL scales of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core30(QLQ C30). |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population | After neoadjuvant study treatment and surgery, up to primary analysis data cut off on 03 ApriI 2020 | ITT population (full population) is defined as all randomized participants. | Number of Participants | NUMBER |
| PRIMARY | Number of Participants With pCR in Subpopulation With PD-L1-Positive Tumor Status (Tumor-infiltrating Immune Cell [IC] 1/2/3) Using AJCC Staging System | After neoadjuvant study treatment and surgery, up to primary analysis data cut off on 03 ApriI 2020 | PD-L1-positive subpopulation is defined as participants in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization. | Number of Participants | NUMBER |
| SECONDARY | Event-Free Survival (EFS) in All Participants | From randomization and up to study final analysis data cut off on 28 September 2022. | ITT population (full population) is defined as all randomized participants. | Months | MEDIAN |
| SECONDARY | Event-Free Survival (EFS) in Subpopulation With PD-L1-Postive Tumor Status | From randomization and up to study final analysis data cut off on 28 September 2022. | PD-L1-positive subpopulation is defined as participants in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization. | Months | NUMBER |
| SECONDARY | Disease-Free Survival (DFS) in All Participants Who Undergo Surgery | From surgery and up to study final analysis data cut off on 28 September 2022. | ITT population (full population) is defined as all randomized participants. Participants who do not undergo surgery at the end of neoadjuvant treatment are excluded from the analysis of DFS. | Months | MEDIAN |
| SECONDARY | Disease-Free Survival (DFS) in Subpopulation of Participants With PD-L1-Positive Tumor Status Who Undergo Surgery | From surgery and up to study final analysis data cut off on 28 September 2022. | PD-L1-positive subpopulation is defined as participants in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization. Participants who do not undergo surgery at the end of neoadjuvant treatment are excluded from the analysis of DFS in the Subpopulation of Participants with PD-L1-Positive Tumor Status. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) in All Participants | From randomization and up to study final analysis data cut off on 28 September 2022. | ITT population (full population) is defined as all randomized participants. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) in Subpopulation With PD-L1-Positive Tumor Status | From randomization and up to study final analysis data cut off on 28 September 2022. | PD-L1-positive subpopulation is defined as participants in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization. | Months | MEDIAN |
| SECONDARY | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | From randomization and up to study final analysis data cut off on 28 September 2022. | All randomized participants with non-missing baseline assessment and at least one non-missing post-baseline assessment. | Score on a 0-100 scale | MEAN |
| SECONDARY | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | From randomization and up to study final analysis data cut off on 28 September 2022. | All randomized participants with non-missing baseline assessment and at least one non-missing post-baseline assessment. | Score on a 0-100 scale. | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group334
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population | Placebo and Chemotherapy | 69 | Number of Participants | ||
| Number of Participants With Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population | Atezolizumab and Chemotherapy | 95 | Number of Participants | ||
| Number of Participants With pCR in Subpopulation With PD-L1-Positive Tumor Status (Tumor-infiltrating Immune Cell [IC] 1/2/3) Using AJCC Staging System | Placebo and Chemotherapy | 37 | Number of Participants | ||
| Number of Participants With pCR in Subpopulation With PD-L1-Positive Tumor Status (Tumor-infiltrating Immune Cell [IC] 1/2/3) Using AJCC Staging System | Atezolizumab and Chemotherapy | 53 | Number of Participants | ||
| Event-Free Survival (EFS) in All Participants | Placebo and Chemotherapy | NA | 95% Confidence Interval NA to NA | Months | |
| Event-Free Survival (EFS) in All Participants | Atezolizumab and Chemotherapy | NA | 95% Confidence Interval NA to NA | Months | |
| Event-Free Survival (EFS) in Subpopulation With PD-L1-Postive Tumor Status | Placebo and Chemotherapy | NA | 95% Confidence Interval NA to NA | Months | |
| Event-Free Survival (EFS) in Subpopulation With PD-L1-Postive Tumor Status | Atezolizumab and Chemotherapy | NA | 95% Confidence Interval NA to NA | Months | |
| Disease-Free Survival (DFS) in All Participants Who Undergo Surgery | Placebo and Chemotherapy | NA | 95% Confidence Interval NA to NA | Months | |
| Disease-Free Survival (DFS) in All Participants Who Undergo Surgery | Atezolizumab and Chemotherapy | NA | 95% Confidence Interval NA to NA | Months |
1 to 10 of 334Source ClinicalTrials.gov
See all 334 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo and Chemotherapy | 168 | |
| Overall Study | STARTED | Atezolizumab and Chemotherapy | 165 | |
| Overall Study | COMPLETED | Placebo and Chemotherapy | 121 | |
| Overall Study | COMPLETED | Atezolizumab and Chemotherapy | 136 | |
| Overall Study | NOT COMPLETED | Placebo and Chemotherapy | 47 | |
| Overall Study | NOT COMPLETED | Atezolizumab and Chemotherapy | 29 |
Source ClinicalTrials.gov
Adverse events298
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 and Chemotherapy | 65 | 167 | 80 |
| other | Anaemia | Blood and lymphatic system disorders | Atezolizumab and Chemotherapy | 64 | 164 | 89 |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo and Chemotherapy | 17 | 167 | 29 |
| other | Leukopenia | Blood and lymphatic system disorders | Atezolizumab and Chemotherapy | 23 | 164 | 46 |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo and Chemotherapy | 59 | 167 | 123 |
| other | Neutropenia | Blood and lymphatic system disorders | Atezolizumab and Chemotherapy | 65 | 164 | 141 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo and Chemotherapy | 5 | 167 | 6 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Atezolizumab and Chemotherapy | 13 | 164 | 16 |
| other | Hypothyroidism | Endocrine disorders | Placebo and Chemotherapy | 0 | 167 | 0 |
| other | Hypothyroidism | Endocrine disorders | Atezolizumab and Chemotherapy | 22 | 164 | 22 |
1 to 10 of 298Source ClinicalTrials.gov
See all 298 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo and Chemotherapy | 28 | 167 |
| Total, all-cause mortality | Atezolizumab and Chemotherapy | 16 | 164 |
| Total, other adverse events | Placebo and Chemotherapy | 167 | 167 |
| Total, other adverse events | Atezolizumab and Chemotherapy | 162 | 164 |
| Total, serious adverse events | Placebo and Chemotherapy | 36 | 167 |
| Total, serious adverse events | Atezolizumab and Chemotherapy | 59 | 164 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Placebo and Chemotherapy vs Atezolizumab and Chemotherapy: deaths from any cause | Trial comparisons |
| Placebo and Chemotherapy vs Atezolizumab and 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/NCT03197935
GET https://conductscience.org/api/trials/v1/NCT03197935/results?page=2