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Clinical trial

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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Last updated:23rd Jun 2015
Identifier: NCT02425891

This multicenter, randomized, double-blind study will evaluate 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.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Randomized, Placebo-Controlled Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer
Actual Study Start Date: June 23, 2015
Estimated Primary Completion Date: April 30, 2020
Estimated Study Completion Date: April 30, 2020

Arms:
- Experimental:
Atezolizumab Plus Nab-Paclitaxel
- Placebo Comparator: Placebo Plus Nab-Paclitaxel

Category Value
Date last updated at source 2019-05-22
Study type(s) Interventional
Expected enrolment 900
Study start date 2015-06-23
Estimated primary completion date 2020-04-30

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