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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)

Trial Status: Closed to Accrual

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.

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: ACTIVE

California

Palo Alto
Stanford Cancer Institute Palo Alto
Status: CLOSED_TO_ACCRUAL
San Francisco
UCSF Medical Center-Mount Zion
Status: CLOSED_TO_ACCRUAL

Connecticut

New Haven
Yale University
Status: ACTIVE

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: CLOSED_TO_ACCRUAL

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: COMPLETED

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: COMPLETED
Dana-Farber Cancer Institute
Status: COMPLETED
Massachusetts General Hospital Cancer Center
Status: COMPLETED

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: ADMINISTRATIVELY_COMPLETE

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: COMPLETED

New York

Bronx
Montefiore Medical Center-Weiler Hospital
Status: CLOSED_TO_ACCRUAL
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: COMPLETED

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: APPROVED

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: CLOSED_TO_ACCRUAL

Texas

Houston
M D Anderson Cancer Center
Status: COMPLETED

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Hoffmann-La Roche

  • Primary ID WO29522
  • Secondary IDs NCI-2015-01149, 2014-005490-37, s14-02148
  • Clinicaltrials.gov ID NCT02425891