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)

Roche

Status and phase: Completed; Phase 3

Conditions: Triple Negative Breast Cancer

Treatments: Drug: Nab-Paclitaxel; Drug: Placebo; Drug: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody

Study type: Interventional

Funder types: Industry

Identifiers

NCT02425891

WO29522

2014-005490-37 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 902 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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902 participants in 2 patient groups, including a placebo group

Atezolizumab Plus Nab-Paclitaxel

Experimental group

Description:

Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.

Treatment:

Drug: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody

Drug: Nab-Paclitaxel

Placebo Plus Nab-Paclitaxel

Placebo Comparator group

Description:

Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.

Treatment:

Drug: Nab-Paclitaxel

Drug: Placebo