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)
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Hoffmann-La Roche
- Study ID
- NCT02425891
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody — DRUGAtezolizumab at a fixed dose of 840 milligrams via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
- Nab-Paclitaxel — DRUGNab-Paclitaxel at a starting dose of 100 milligrams per square meter via IV infusion on Days 1, 8, and 15 of each 28-day cycle. Nab-Paclitaxel was administered for a target of at least 6 cycles, with no maximum in the absence of disease progression or unacceptable toxicity.
- Placebo — DRUGPlacebo administered via IV infusion on Days 1 and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
Study Details
This multicenter, randomized, double-blind study evaluated the efficacy, safety, and pharmacokinetics of atezolizumab (MPDL3280A) administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC). The safety of single-agent nab-paclitaxel has been determined in previous studies of participants with mBC and the safety data to date suggest that atezolizumab can be safely combined with standard chemotherapy agents.
Key Dates
- Start date
- Jun 23, 2015
- Status verified
- Jun 2022
- Primary completion
- Apr 14, 2020
- Completion
- Aug 31, 2021
Study Design
- Enrollment
- 902 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Atezolizumab Plus Nab-PaclitaxelParticipants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
- Placebo Comparator: Placebo Plus Nab-PaclitaxelParticipants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
Primary Outcome Measure
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in All Randomized Participants [ Time Frame: Baseline up to approximately 34 months ]
Locations (49)
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