Trial · NCT03125902
A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)
NCT03125902, Phase 3, Completed, Hoffmann-La Roche; results first posted 2021-01-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC). Trials, record NCT03125902. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03125902
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)
- NCT number
- NCT03125902
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 653 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Triple-Negative Breast Cancer
- Interventions
- Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody, Atezolizumab Placebo, Paclitaxel
- First posted
- 2017-04-24
- Last updated
- 2024-03-26
- Other registries' IDs
- eudract:2016-004024-29
- Results first posted
- 2021-01-07
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Subpopulation With Programmed Death-Ligand 1 (PD-L1)-Positive Tumour Status | From Day 1 to disease progression (PD) or death from any cause, assessed up to primary completion date (approximately 26 months) | PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (\>/=) 20 percent (%) relative increase and \>/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. |
| Primary | Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Intent-to-Treat (ITT) Population | From Day 1 to disease progression (PD) or death from any cause, assessed up to primary completion date (approximately 26 months) | PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (\>/=) 20 percent (%) relative increase and \>/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. |
| Secondary | Overall Survival (OS) in the PD-L1-Positive Subpopulation | From Day 1 to death from any cause, assessed up 36 months | OS is defined as the time from randomization to death from any cause. Results from a pre-specified interim analysis. |
| Secondary | Overall Survival (OS) in the ITT Population | From Day 1 to death from any cause, assessed up to end of study (up to approximately 36 months) | OS is defined as the time from randomization to death from any cause. Results from a pre-specified interim analysis. |
| Secondary | Percentage of Participants Who Are Alive at 12 and 18 Months | From Day 1 to death from any cause, assessed up to 12 and 18 months | |
| Secondary | Time to Deterioration (TTD) in Global Health Status/ Health Related Quality of Life (HRQoL) in the PRO Evaluable Population | From Day 1 to deterioration, assessed up 64 months | Deterioration in Global Health Status/HRQoL is defined as a decrease of at least 10 points on the Global Health Status /HRQoL scale (comprised of 2 items: 29 and 30) of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The 2 items use 7-point scale (1 = very poor to 7 = Excellent). Scores are averaged, transformed to 0-100 scale; where higher score=better level of functioning or greater degree of symptoms. |
| Secondary | Percentage of Participants Who Are Alive Without Progression Event at Month 12 Assessed Using RECIST v1.1 | From Day 1 to PD or death from any cause, assessed up to 12 months | PD is defined as \>/=20% relative increase and \>/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. |
| Secondary | Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the PD-L1-Positive Population (Confirmed, Investigator-Assessed ) | From Day 1 to PD, assessed up to primary completion date (approximately 26 months) | Objective response is defined as complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (\<) 10mm for nodal TLs/ non-TLs. PR is defined as \>/=30% decrease in SD of TLs, taking as reference the baseline SD. Responses were confirmed after 8 weeks if within first 12 months or after 12 weeks if later. |
| Secondary | Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the PD-L1-Positive Population (Unconfirmed, Investigator-Assessed) | From Day 1 to PD, assessed up to primary completion date (approximately 26 months) | Objective response is defined as complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (\<) 10mm for nodal TLs/ non-TLs. PR is defined as \>/=30% decrease in SD of TLs, taking as reference the baseline SD. |
| Secondary | Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the Response-Evaluable Population (Confirmed, Investigator-Assessed ) | From Day 1 to PD, assessed up to primary completion date (approximately 26 months) | Objective response is defined as complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (\<) 10mm for nodal TLs/ non-TLs. PR is defined as \>/=30% decrease in SD of TLs, taking as reference the baseline SD. Responses were confirmed after 8 weeks if within first 12 months or after 12 weeks if later. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Subpopulation With Programmed Death-Ligand 1 (PD-L1)-Positive Tumour Status | From Day 1 to disease progression (PD) or death from any cause, assessed up to primary completion date (approximately 26 months) | PD-L1-positive subpopulation: participants in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization | Months | MEDIAN |
| PRIMARY | Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Intent-to-Treat (ITT) Population | From Day 1 to disease progression (PD) or death from any cause, assessed up to primary completion date (approximately 26 months) | ITT population: all randomized participants, whether or not the assigned study treatment was received | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) in the PD-L1-Positive Subpopulation | From Day 1 to death from any cause, assessed up 36 months | PD-L1-positive subpopulation: participants in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) in the ITT Population | From Day 1 to death from any cause, assessed up to end of study (up to approximately 36 months) | ITT population: all randomized participants, whether or not the assigned study treatment was received | Months | MEDIAN |
| SECONDARY | Percentage of Participants Who Are Alive at 12 and 18 Months | From Day 1 to death from any cause, assessed up to 12 and 18 months | ITT population: all randomized participants, whether or not the assigned study treatment was received | Percentage of Participants | NUMBER |
| SECONDARY | Time to Deterioration (TTD) in Global Health Status/ Health Related Quality of Life (HRQoL) in the PRO Evaluable Population | From Day 1 to deterioration, assessed up 64 months | PRO-evaluable populations: participants in the ITT population with baseline PRO assessment and at least one post-baseline PRO assessment in the questionnaire of interest (European Organization for the Research and Treatment of Cancer \[EORTC\] Quality-of-life Questionnaire \[QLQ\] C30, EORTC QLQ BR-23 or FACT-G) | Months | MEDIAN |
| SECONDARY | Percentage of Participants Who Are Alive Without Progression Event at Month 12 Assessed Using RECIST v1.1 | From Day 1 to PD or death from any cause, assessed up to 12 months | ITT population: all randomized participants, whether or not the assigned study treatment was received | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the PD-L1-Positive Population (Confirmed, Investigator-Assessed ) | From Day 1 to PD, assessed up to primary completion date (approximately 26 months) | PD-L1-positive subpopulation: participants in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the PD-L1-Positive Population (Unconfirmed, Investigator-Assessed) | From Day 1 to PD, assessed up to primary completion date (approximately 26 months) | PD-L1-positive subpopulation: participants in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the Response-Evaluable Population (Confirmed, Investigator-Assessed ) | From Day 1 to PD, assessed up to primary completion date (approximately 26 months) | Response-evaluable population: participants in the ITT population with measurable disease at baseline | Percentage of Participants | NUMBER |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Subpopulation With Programmed Death-Ligand 1 (PD-L1)-Positive Tumour Status | Placebo and Paclitaxel | 5.72 | 95% Confidence Interval 5.39 to 7.20 | Months | |
| Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Subpopulation With Programmed Death-Ligand 1 (PD-L1)-Positive Tumour Status | Atezolizumab and Paclitaxel | 5.95 | 95% Confidence Interval 5.62 to 7.43 | Months | |
| Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Intent-to-Treat (ITT) Population | Placebo and Paclitaxel | 5.55 | 95% Confidence Interval 5.36 to 6.51 | Months | |
| Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Intent-to-Treat (ITT) Population | Atezolizumab and Paclitaxel | 5.68 | 95% Confidence Interval 5.42 to 7.16 | Months | |
| Overall Survival (OS) in the PD-L1-Positive Subpopulation | Placebo and Paclitaxel | 28.29 | 95% Confidence Interval 19.06 to NA | Months | |
| Overall Survival (OS) in the PD-L1-Positive Subpopulation | Atezolizumab and Paclitaxel | 22.05 | 95% Confidence Interval 19.19 to 30.52 | Months | |
| Overall Survival (OS) in the ITT Population | Placebo and Paclitaxel | 22.80 | 95% Confidence Interval 17.08 to 28.29 | Months | |
| Overall Survival (OS) in the ITT Population | Atezolizumab and Paclitaxel | 19.19 | 95% Confidence Interval 16.59 to 22.05 | Months | |
| Percentage of Participants Who Are Alive at 12 and 18 Months | Placebo and Paclitaxel | 12 months | 73.47 | 95% Confidence Interval 67.44 to 79.49 | Percentage of Participants |
| Percentage of Participants Who Are Alive at 12 and 18 Months | Atezolizumab and Paclitaxel | 12 months | 68.86 | 95% Confidence Interval 64.37 to 73.34 | Percentage of Participants |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 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 + Paclitaxel | 220 | |
| Overall Study | STARTED | Atezolizumab + Paclitaxel | 431 | |
| Overall Study | COMPLETED | Placebo + Paclitaxel | 0 | |
| Overall Study | COMPLETED | Atezolizumab + Paclitaxel | 0 | |
| Overall Study | NOT COMPLETED | Placebo + Paclitaxel | 220 | |
| Overall Study | NOT COMPLETED | Atezolizumab + Paclitaxel | 431 |
Source ClinicalTrials.gov
Adverse events358
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 | Atezolizumab + Paclitaxel | 128 | 431 | 277 |
| other | ANAEMIA | Blood and lymphatic system disorders | Placebo + Paclitaxel | 66 | 220 | 134 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Atezolizumab + Paclitaxel | 56 | 431 | 181 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Placebo + Paclitaxel | 20 | 220 | 44 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Atezolizumab + Paclitaxel | 98 | 431 | 253 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Placebo + Paclitaxel | 48 | 220 | 103 |
| other | HYPERTHYROIDISM | Endocrine disorders | Atezolizumab + Paclitaxel | 25 | 431 | 28 |
| other | HYPERTHYROIDISM | Endocrine disorders | Placebo + Paclitaxel | 0 | 220 | 0 |
| other | HYPOTHYROIDISM | Endocrine disorders | Atezolizumab + Paclitaxel | 49 | 431 | 65 |
| other | HYPOTHYROIDISM | Endocrine disorders | Placebo + Paclitaxel | 6 | 220 | 6 |
1 to 10 of 358Source ClinicalTrials.gov
See all 358 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Atezolizumab + Paclitaxel | 229 | 431 |
| Total, all-cause mortality | Placebo + Paclitaxel | 119 | 220 |
| Total, other adverse events | Atezolizumab + Paclitaxel | 421 | 431 |
| Total, other adverse events | Placebo + Paclitaxel | 209 | 220 |
| Total, serious adverse events | Atezolizumab + Paclitaxel | 112 | 431 |
| Total, serious adverse events | Placebo + Paclitaxel | 40 | 220 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34219000 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Atezolizumab + Paclitaxel vs Placebo + Paclitaxel: deaths from any cause | Trial comparisons |
| Atezolizumab + Paclitaxel vs Placebo + Paclitaxel: 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/NCT03125902
GET https://conductscience.org/api/trials/v1/NCT03125902/registered?page=2