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)
Condition: Triple Negative Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Intervention: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody; Nab-Paclitaxel; Placebo
Intervention description: Atezolizumab at a fixed dose of 840 milligrams via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle until disease progression or unacceptable toxicity.; Nab-Paclitaxel at a starting dose of 100 milligrams per square meter via IV infusion on Days 1, 8, and 15 of each 28-day cycle. Nab-Paclitaxel was administered for a target of at least 6 cycles, with no maximum in the absence of disease progression or unacceptable toxicity.; Placebo administered via IV infusion on Days 1 and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
Intervention MeSH terms: Paclitaxel; Atezolizumab; Antibodies; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 902.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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