Trial · NCT03498716
A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer
NCT03498716, Phase 3, Terminated, Hoffmann-La Roche; results first posted 2024-08-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer. Trials, record NCT03498716. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03498716
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer
- NCT number
- NCT03498716
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 2,199 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Triple Negative Breast Cancer
- Interventions
- Atezolizumab, Paclitaxel, Dose-dense Doxorubicin or dose-dense Epirubicin, Cyclophosphamide
- First posted
- 2018-04-17
- Last updated
- 2024-08-21
- Other registries' IDs
- eudract:2016-003695-47
- Results first posted
- 2024-08-21
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Invasive Disease-Free Survival (iDFS) | From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years) | 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. |
| Secondary | Invasive Disease-Free Survival (iDFS) in the Subpopulation With Programmed Death-ligand 1 (PD-L1) Selected Tumor Status (IC1/2/3) | From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years) | 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. |
| Secondary | Invasive Disease-Free Survival (iDFS) in the Node Positive Subpopulation | From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years) | 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. |
| Secondary | Overall Survival (OS) | From randomization up to death from any cause (up to 5 years) | 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. |
| Secondary | Invasive Disease-Free Survival (iDFS) Including Second Primary Non-Breast Invasive Cancer | From randomization up to death from any cause (up to 5 years) | 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. |
| Secondary | Recurrence-Free Interval (RFI) | From randomization up to 5 years | 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. |
| Secondary | Distant Recurrence-Free Interval (DRFI) | From randomization up to 5 years | 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. |
| Secondary | Disease-Free Survival (DFS) | From randomization up to first disease recurrence or death from any cause (up to 5 years) | 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. |
| Secondary | 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]) | 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 | 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. |
| Secondary | Change From Baseline in EORTC QLQ-C30 Patient-reported Function (Physical Functioning [Q1-Q5]) | 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 | 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. |
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 | Invasive Disease-Free Survival (iDFS) | From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years) | ITT population included all randomized participants, whether or not the assigned study treatment was received. | months | MEDIAN |
| SECONDARY | Invasive Disease-Free Survival (iDFS) in the Subpopulation With Programmed Death-ligand 1 (PD-L1) Selected Tumor Status (IC1/2/3) | From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years) | PD-L1-positive subpopulation included participants in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization. ITT population included all randomized participants, whether or not the assigned study treatment was received. | months | MEDIAN |
| SECONDARY | Invasive Disease-Free Survival (iDFS) in the Node Positive Subpopulation | From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years) | Node positive subpopulation included all participants in the ITT population whose lymph node (LN) status was positive at the time of randomization. ITT population included all randomized participants, whether or not the assigned study treatment was received. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From randomization up to death from any cause (up to 5 years) | ITT population included all randomized participants, whether or not the assigned study treatment was received. | months | MEDIAN |
| SECONDARY | Invasive Disease-Free Survival (iDFS) Including Second Primary Non-Breast Invasive Cancer | From randomization up to death from any cause (up to 5 years) | ITT population included all randomized participants, whether or not the assigned study treatment was received. | months | MEDIAN |
| SECONDARY | Recurrence-Free Interval (RFI) | From randomization up to 5 years | ITT population included all randomized participants, whether or not the assigned study treatment was received. | months | MEDIAN |
| SECONDARY | Distant Recurrence-Free Interval (DRFI) | From randomization up to 5 years | ITT population included all randomized participants, whether or not the assigned study treatment was received. | months | MEDIAN |
| SECONDARY | Disease-Free Survival (DFS) | From randomization up to first disease recurrence or death from any cause (up to 5 years) | ITT population included all randomized participants, whether or not the assigned study treatment was received. | months | MEDIAN |
| SECONDARY | 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]) | 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 | Patient-reported outcome (PRO)-evaluable populations included participants in the ITT population with baseline PRO assessment and at least one post-baseline PRO assessment in the EORTC QLQC30. ITT population included all randomized participants, whether or not the assigned study treatment was received. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis at the specified time point. | score on scale | MEAN |
| SECONDARY | Change From Baseline in EORTC QLQ-C30 Patient-reported Function (Physical Functioning [Q1-Q5]) | 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 | PRO-evaluable populations included participants in the ITT population with baseline PRO assessment and at least one post-baseline PRO assessment in the EORTC QLQC30. ITT population included all randomized participants, whether or not the assigned study treatment was received. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis at the specified time point. | score on scale | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group136
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Invasive Disease-Free Survival (iDFS) | Chemotherapy | NA | 95% Confidence Interval NA to NA | months | |
| Invasive Disease-Free Survival (iDFS) | Atezolizumab and Chemotherapy | NA | 95% Confidence Interval NA to NA | months | |
| Invasive Disease-Free Survival (iDFS) in the Subpopulation With Programmed Death-ligand 1 (PD-L1) Selected Tumor Status (IC1/2/3) | Chemotherapy | NA | 95% Confidence Interval NA to NA | months | |
| Invasive Disease-Free Survival (iDFS) in the Subpopulation With Programmed Death-ligand 1 (PD-L1) Selected Tumor Status (IC1/2/3) | Atezolizumab and Chemotherapy | NA | 95% Confidence Interval NA to NA | months | |
| Invasive Disease-Free Survival (iDFS) in the Node Positive Subpopulation | Chemotherapy | NA | 95% Confidence Interval NA to NA | months | |
| Invasive Disease-Free Survival (iDFS) in the Node Positive Subpopulation | Atezolizumab and Chemotherapy | NA | 95% Confidence Interval NA to NA | months | |
| Overall Survival (OS) | Chemotherapy | NA | 95% Confidence Interval NA to NA | months | |
| Overall Survival (OS) | Atezolizumab and Chemotherapy | NA | 95% Confidence Interval NA to NA | months | |
| Invasive Disease-Free Survival (iDFS) Including Second Primary Non-Breast Invasive Cancer | Chemotherapy | NA | 95% Confidence Interval NA to NA | months | |
| Invasive Disease-Free Survival (iDFS) Including Second Primary Non-Breast Invasive Cancer | Atezolizumab and Chemotherapy | NA | 95% Confidence Interval NA to NA | months |
1 to 10 of 136Source ClinicalTrials.gov
See all 136 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chemotherapy | 1,098 | |
| Overall Study | STARTED | Atezolizumab and Chemotherapy | 1,101 | |
| Overall Study | Safety Evaluable Population | Chemotherapy | 1,084 | |
| Overall Study | Safety Evaluable Population | Atezolizumab and Chemotherapy | 1,093 | |
| Overall Study | COMPLETED | Chemotherapy | 0 | |
| Overall Study | COMPLETED | Atezolizumab and Chemotherapy | 0 | |
| Overall Study | NOT COMPLETED | Chemotherapy | 1,098 | |
| Overall Study | NOT COMPLETED | Atezolizumab and Chemotherapy | 1,101 |
Source ClinicalTrials.gov
Adverse events538
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 | Chemotherapy | 422 | 1,084 | 546 |
| other | Anaemia | Blood and lymphatic system disorders | Atezolizumab and Chemotherapy | 420 | 1,093 | 586 |
| other | Leukopenia | Blood and lymphatic system disorders | Chemotherapy | 139 | 1,084 | 274 |
| other | Leukopenia | Blood and lymphatic system disorders | Atezolizumab and Chemotherapy | 137 | 1,093 | 317 |
| other | Neutropenia | Blood and lymphatic system disorders | Chemotherapy | 240 | 1,084 | 437 |
| other | Neutropenia | Blood and lymphatic system disorders | Atezolizumab and Chemotherapy | 236 | 1,093 | 474 |
| other | Hyperthyroidism | Endocrine disorders | Chemotherapy | 3 | 1,084 | 3 |
| other | Hyperthyroidism | Endocrine disorders | Atezolizumab and Chemotherapy | 62 | 1,093 | 65 |
| other | Hypothyroidism | Endocrine disorders | Chemotherapy | 6 | 1,084 | 6 |
| other | Hypothyroidism | Endocrine disorders | Atezolizumab and Chemotherapy | 161 | 1,093 | 173 |
1 to 10 of 538Source ClinicalTrials.gov
See all 538 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chemotherapy | 58 | 1,098 |
| Total, all-cause mortality | Atezolizumab and Chemotherapy | 72 | 1,101 |
| Total, other adverse events | Chemotherapy | 1,068 | 1,084 |
| Total, other adverse events | Atezolizumab and Chemotherapy | 1,082 | 1,093 |
| Total, serious adverse events | Chemotherapy | 173 | 1,084 |
| Total, serious adverse events | Atezolizumab and Chemotherapy | 280 | 1,093 |
Source ClinicalTrials.gov
Papers2
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Chemotherapy vs Atezolizumab and Chemotherapy: Number of Participants With Adverse Events (AE) | Trial comparisons |
| Chemotherapy vs Atezolizumab and Chemotherapy: deaths from any cause | Trial comparisons |
| 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.
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Read this trial from software.
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