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)
Completed · Phase 3 · Has a placebo group
Conditions studied: Triple Negative Breast Cancer
In brief
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 facts
- Study ID
- NCT02425891
- Run by
- Hoffmann-La Roche
- People needed
- 902
- Starts
- 2015-06-23
- Expected to finish
- 2021-08-31
- Last updated by the study team
- 2022-07-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Metastatic or locally advanced, histologically documented TNBC characterized by absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) expression
- No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC
- Eligible for taxane monotherapy (i.e., absence of rapid clinical progression, life-threatening visceral metastases, or the need for rapid symptom and/or disease control)
- A representative formalin-fixed, paraffin-embedded tumor specimen in paraffin blocks, or at least 20 unstained slides with an associated pathology report documenting ER, PR, and HER2 negativity. Participants with fewer than 20 unstained slides available at baseline, and not fewer than 12 unstained slides will be eligible upon discussion with Medical Monitor
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Measurable disease as defined by RECIST v1.1
- Adequate hematologic and end-organ function
You may not qualify if…
- Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases
- Leptomeningeal disease
- Pregnancy or lactation
- History of autoimmune disease
- Prior allogeneic stem cell or solid organ transplantation
- Positive test for human immunodeficiency virus
- Active hepatitis B or hepatitis C
- Receipt of a live, attenuated vaccine within 4 weeks prior to randomization, during treatment, or within 5 months following the last dose of atezolizumab/placebo
Where it is running
- Highlands Oncology Group — Springdale, Arkansas, United States
- Kaiser Permanente of Northern California — Oakland, California, United States
- Emad Ibrahim, Md, Inc — Redlands, California, United States
- Univ of Calif, San Francisco; Breast Cancer Center — San Francisco, California, United States
- Kaiser Permanente - San Marcos — San Marcos, California, United States
- Cancer Research Collaboration, Inc. — Santa Ana, California, United States
- Stanford Univ School of Med; Oncology — Stanford, California, United States
- Kaiser Permanente Of Colorado — Aurora, Colorado, United States
- Yale Cancer Center; Medical Oncology — New Haven, Connecticut, United States
- Norwalk Hospital — Norwalk, Connecticut, United States
- Stamford Hospital; BCC, MOHR — Stamford, Connecticut, United States
- MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center) — Washington D.C., District of Columbia, United States
- Florida Cancer Specialists - SCRI; Pharmacy — Fort Myers, Florida, United States
- Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy) — Jacksonville, Florida, United States
- The Mount Siani Comprehensive Cancer Center — Miami Beach, Florida, United States
- Florida Cancer Research Institute — Plantation, Florida, United States
- Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building) — St. Petersburg, Florida, United States
- Northwest Georgia Oncology Centers PC - Marietta — Marietta, Georgia, United States
- Rush University Medical Center - Chicago — Chicago, Illinois, United States
- Mercy Medical Center — Baltimore, Maryland, United States
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
- Maryland Oncology Hematology — Rochville, Maryland, United States
- Barbara Ann Karmanos Cancer Institute; Oncology — Detroit, Michigan, United States
- West Michigan Cancer Center — Kalamazoo, Michigan, United States
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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