IMpassion130: This phase III trial is assessing the safety of using a new drug (MPDL3280A) in combination with nab-paclitaxel (a chemotherapy drug) for the treatment of people with metastatic breast cancerA phase III, multicenter, randomised, placebo-controlled study of MPDL3280A (anti-PD-L1 Antibody) in combination with Nab-Paclitaxel for patients with previously untreated metastatic triple-negative breast cancer

Inclusion

• 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