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)
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| ClinicalTrials.gov Identifier: NCT02425891 |
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Recruitment Status :
Completed
First Posted : April 24, 2015
Results First Posted : May 17, 2021
Last Update Posted : July 19, 2022
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
- Study Details
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- Study Results
- Disclaimer
- How to Read a Study Record
| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
| Condition |
Triple Negative Breast Cancer |
| Interventions |
Drug: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody Drug: Nab-Paclitaxel Drug: Placebo |
| Enrollment | 902 |
Participant Flow
| Recruitment Details | The observation of Overall Survival events was complete. Participants still on treatment were handed over to follow-up programs or studies. The study status is "Completed" but some participants discontinued the study because the Sponsor terminated it after it reached the "Completed" state. |
| Pre-assignment Details |
| Arm/Group Title | Placebo Plus Nab-Paclitaxel | Atezolizumab Plus Nab-Paclitaxel |
|---|---|---|
 Arm/Group Description |
Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity. | Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity. |
| Period Title: Overall Study | ||
| Started | 451 | 451 |
| Completed | 0 | 0 |
| Not Completed | 451 | 451 |
| Reason Not Completed | ||
| Death | 333 | 314 |
| Lost to Follow-up | 4 | 6 |
| Non-Compliance | 1 | 1 |
| Accidentally randomized screen failure participant | 0 | 1 |
| Physician Decision | 0 | 1 |
| Protocol Violation | 1 | 1 |
| Study Terminated By Sponsor | 85 | 95 |
| Withdrawal by Subject | 27 | 32 |
Baseline Characteristics
| Arm/Group Title | Placebo Plus Nab-Paclitaxel | Atezolizumab Plus Nab-Paclitaxel | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity. | Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 451 | 451 | 902 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 451 participants | 451 participants | 902 participants | |
| 55.4 (12.1) | 54.3 (12.3) | 54.9 (12.2) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 451 participants | 451 participants | 902 participants | |
| Female |
450 99.8%
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449 99.6%
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899 99.7%
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| Male |
1 0.2%
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2 0.4%
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3 0.3%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 451 participants | 451 participants | 902 participants | |
| Hispanic or Latino |
83 18.4%
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60 13.3%
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143 15.9%
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| Not Hispanic or Latino |
340 75.4%
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368 81.6%
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708 78.5%
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| Unknown or Not Reported |
28 6.2%
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23 5.1%
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51 5.7%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 451 participants | 451 participants | 902 participants | |
| American Indian or Alaska Native |
23 5.1%
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17 3.8%
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40 4.4%
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| Asian |
76 16.9%
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85 18.8%
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161 17.8%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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1 0.2%
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1 0.1%
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| Black or African American |
32 7.1%
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26 5.8%
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58 6.4%
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| White |
301 66.7%
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308 68.3%
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609 67.5%
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| More than one race |
3 0.7%
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2 0.4%
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5 0.6%
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| Unknown or Not Reported |
16 3.5%
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12 2.7%
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28 3.1%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
| Name/Title: | Medical Communications |
| Organization: | Hoffmann-La Roche |
| Phone: | 800-821-8590 |
| EMail: | genentech@druginfo.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT02425891 |
| Other Study ID Numbers: |
WO29522 2014-005490-37 ( EudraCT Number ) |
| First Submitted: | April 21, 2015 |
| First Posted: | April 24, 2015 |
| Results First Submitted: | March 24, 2021 |
| Results First Posted: | May 17, 2021 |
| Last Update Posted: | July 19, 2022 |