Trial · NCT02425891
A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130)
NCT02425891, Phase 3, Completed, Hoffmann-La Roche; results first posted 2021-05-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130). Trials, record NCT02425891. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02425891
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130)
- NCT number
- NCT02425891
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 902 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Triple Negative Breast Cancer
- Interventions
- Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody, Nab-Paclitaxel, Placebo
- First posted
- 2015-04-24
- Last updated
- 2022-07-19
- Other registries' IDs
- eudract:2014-005490-37
- Results first posted
- 2021-05-17
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in All Randomized Participants | Baseline up to approximately 34 months | PFS was defined as the time from randomization to the occurrence of disease progression, as determined by investigators from tumor assessments per RECIST v1.1, or death from any cause, whichever occurred first. |
| Primary | PFS According to RECIST v1.1 in Participants With Detectable Programmed Death-Ligand 1 (PD-L1) | Baseline up to approximately 34 months | PFS was defined as the time from randomization to the occurrence of disease progression, as determined by investigators from tumor assessments per RECIST v1.1, or death from any cause, whichever occurred first. |
| Primary | Overall Survival (OS) in All Randomized Participants | Baseline until death due to any cause (up to approximately 58 months) | OS was defined as the time from the date of randomization to the date of death from any cause. |
| Primary | OS in Participants With Detectable PD-L1 | Baseline until death due to any cause (up to approximately 58 months) | OS was defined as the time from the date of randomization to the date of death from any cause. |
| Secondary | Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 in All Randomized Participants | Baseline up to approximately 34 months | An objective response was defined for participants with measurable disease at baseline as either a partial response (PR) or a complete response (CR) using RECIST v1.1. |
| Secondary | Percentage of Participants With an Objective Response of CR or PR According to RECIST v1.1 in Participants With Detectable PD-L1 | Baseline up to approximately 34 months | An objective response was defined for participants with measurable disease at baseline as either a partial response (PR) or a complete response (CR) using RECIST v1.1. |
| Secondary | Duration of Response (DOR) According to RECIST v1.1 in All Randomized Participants | Baseline up to approximately 34 months | DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause, whichever occurred first. |
| Secondary | DOR Acccording to RECIST v1.1 in Participants With Detectable PD-L1 | Baseline up to approximately 34 months | DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause, whichever occurred first. |
| Secondary | Time to Deterioration (TTD) in Global Health Status/Health Related Quality of Life According to European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) v3.0 in All Randomized Participants | Baseline up to approximately 58 months | Deterioration in GHS/HRQoL (Items 29, 30 of the EORTC QLQ C30) was defined by the following two criteria: 1. The time from randomization to the first time the participant's GHS/HRQoL scale score showed a \>=10-point decrease from the baseline scale score. A 10-point change was defined as the minimally important difference (MID). 2. The score decrease of \>= 10-points from baseline was held for at least two consecutive cycles, or an initial score decrease of \>= 10-points was followed by death or treatment discontinuation within 3 weeks from the last assessment. |
| Secondary | TTD in Global Health Status/Health Related Quality of Life According to EORTC QLQ-C30 v3.0 in Participants With Detectable PD-L1 | Baseline up to approximately 58 months | Deterioration in GHS/HRQoL (Items 29, 30 of the EORTC QLQ C30) was defined by the following two criteria: 1. The time from randomization to the first time the participants's GHS/HRQoL scale score showed a \>=10-point decrease from the baseline scale score. A 10-point change was defined as the minimally important difference (MID). 2. The score decrease of \>= 10-points from baseline was held for at least two consecutive cycles, or an initial score decrease of \>= 10-points was followed by death or treatment discontinuation within 3 weeks from the last assessment. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
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) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in All Randomized Participants | Baseline up to approximately 34 months | The ITT population is defined as all randomized patients, whether or not the assigned study treatment was received. | Months | MEDIAN |
| PRIMARY | PFS According to RECIST v1.1 in Participants With Detectable Programmed Death-Ligand 1 (PD-L1) | Baseline up to approximately 34 months | The PD-L1-selected subpopulation is defined as patients in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization. | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) in All Randomized Participants | Baseline until death due to any cause (up to approximately 58 months) | The ITT population is defined as all randomized patients, whether or not the assigned study treatment was received. | Months | MEDIAN |
| PRIMARY | OS in Participants With Detectable PD-L1 | Baseline until death due to any cause (up to approximately 58 months) | The PD-L1-selected subpopulation is defined as patients in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 in All Randomized Participants | Baseline up to approximately 34 months | The ORR-evaluable population is defined as patients in the ITT population with measurable disease at baseline. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With an Objective Response of CR or PR According to RECIST v1.1 in Participants With Detectable PD-L1 | Baseline up to approximately 34 months | The PD-L1-ORR-evaluable population is defined as patients in the PD-L1-selected subpopulation with measurable disease at baseline. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) According to RECIST v1.1 in All Randomized Participants | Baseline up to approximately 34 months | The duration of response (DOR)-evaluable population is defined as patients with an objective response. | Months | NUMBER |
| SECONDARY | DOR Acccording to RECIST v1.1 in Participants With Detectable PD-L1 | Baseline up to approximately 34 months | The duration of response (DOR)-evaluable population is defined as patients with an objective response. | Months | NUMBER |
| SECONDARY | Time to Deterioration (TTD) in Global Health Status/Health Related Quality of Life According to European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) v3.0 in All Randomized Participants | Baseline up to approximately 58 months | The patient-reported outcome (PRO)-evaluable population is defined as patients in the ITT population with a baseline and ≥1 post-baseline PRO assessment. | Months | MEDIAN |
| SECONDARY | TTD in Global Health Status/Health Related Quality of Life According to EORTC QLQ-C30 v3.0 in Participants With Detectable PD-L1 | Baseline up to approximately 58 months | The patient-reported outcome (PRO)-evaluable population is defined as patients in the ITT population with a baseline and ≥1 post-baseline PRO assessment. | Months | MEDIAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group37
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) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in All Randomized Participants | Placebo Plus Nab-Paclitaxel | 5.49 | 95% Confidence Interval 5.32 to 5.59 | Months | |
| Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in All Randomized Participants | Atezolizumab Plus Nab-Paclitaxel | 7.16 | 95% Confidence Interval 5.59 to 7.46 | Months | |
| PFS According to RECIST v1.1 in Participants With Detectable Programmed Death-Ligand 1 (PD-L1) | Placebo Plus Nab-Paclitaxel | 4.96 | 95% Confidence Interval 3.81 to 5.55 | Months | |
| PFS According to RECIST v1.1 in Participants With Detectable Programmed Death-Ligand 1 (PD-L1) | Atezolizumab Plus Nab-Paclitaxel | 7.46 | 95% Confidence Interval 6.70 to 9.23 | Months | |
| Overall Survival (OS) in All Randomized Participants | Placebo Plus Nab-Paclitaxel | 18.73 | 95% Confidence Interval 16.85 to 20.76 | Months | |
| Overall Survival (OS) in All Randomized Participants | Atezolizumab Plus Nab-Paclitaxel | 21.03 | 95% Confidence Interval 19.02 to 23.36 | Months | |
| OS in Participants With Detectable PD-L1 | Placebo Plus Nab-Paclitaxel | 17.91 | 95% Confidence Interval 13.63 to 20.30 | Months | |
| OS in Participants With Detectable PD-L1 | Atezolizumab Plus Nab-Paclitaxel | 25.43 | 95% Confidence Interval 19.55 to 30.69 | Months | |
| Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 in All Randomized Participants | Placebo Plus Nab-Paclitaxel | 45.9 | Percentage of Participants | ||
| Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 in All Randomized Participants | Atezolizumab Plus Nab-Paclitaxel | 56.0 | Percentage of Participants |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 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 Plus Nab-Paclitaxel | 451 | |
| Overall Study | STARTED | Atezolizumab Plus Nab-Paclitaxel | 451 | |
| Overall Study | COMPLETED | Placebo Plus Nab-Paclitaxel | 0 | |
| Overall Study | COMPLETED | Atezolizumab Plus Nab-Paclitaxel | 0 | |
| Overall Study | NOT COMPLETED | Placebo Plus Nab-Paclitaxel | 451 | |
| Overall Study | NOT COMPLETED | Atezolizumab Plus Nab-Paclitaxel | 451 |
Source ClinicalTrials.gov
Adverse events486
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 (q2w) + Nab-Paclitaxel | 115 | 430 | 186 |
| other | ANAEMIA | Blood and lymphatic system disorders | Atezolizumab (q2w) + Nab-Paclitaxel | 129 | 460 | 221 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Placebo (q2w) + Nab-Paclitaxel | 23 | 430 | 50 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Atezolizumab (q2w) + Nab-Paclitaxel | 30 | 460 | 68 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Placebo (q2w) + Nab-Paclitaxel | 66 | 430 | 176 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Atezolizumab (q2w) + Nab-Paclitaxel | 101 | 460 | 238 |
| other | HYPOTHYROIDISM | Endocrine disorders | Placebo (q2w) + Nab-Paclitaxel | 15 | 430 | 15 |
| other | HYPOTHYROIDISM | Endocrine disorders | Atezolizumab (q2w) + Nab-Paclitaxel | 67 | 460 | 80 |
| other | DRY EYE | Eye disorders | Placebo (q2w) + Nab-Paclitaxel | 15 | 430 | 15 |
| other | DRY EYE | Eye disorders | Atezolizumab (q2w) + Nab-Paclitaxel | 31 | 460 | 33 |
1 to 10 of 486Source ClinicalTrials.gov
See all 486 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo (q2w) + Nab-Paclitaxel | 333 | 451 |
| Total, all-cause mortality | Atezolizumab (q2w) + Nab-Paclitaxel | 314 | 451 |
| Total, other adverse events | Placebo (q2w) + Nab-Paclitaxel | 414 | 430 |
| Total, other adverse events | Atezolizumab (q2w) + Nab-Paclitaxel | 450 | 460 |
| Total, serious adverse events | Placebo (q2w) + Nab-Paclitaxel | 80 | 430 |
| Total, serious adverse events | Atezolizumab (q2w) + Nab-Paclitaxel | 110 | 460 |
Source ClinicalTrials.gov
Papers5
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 (q2w) + Nab-Paclitaxel vs Atezolizumab (q2w) + Nab-Paclitaxel: deaths from any cause | Trial comparisons |
| Placebo (q2w) + Nab-Paclitaxel vs Atezolizumab (q2w) + Nab-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/NCT02425891
GET https://conductscience.org/api/trials/v1/NCT02425891/results?page=2