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)

  • Cancer
  • Breast Cancer
  • Triple Negative Breast Cancer
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Completed

This trial runs in
Countries
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Bosnia and Herzegovina
  • Brazil
  • Canada
  • Chile
  • Colombia
  • Costa Rica
  • Czechia
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Guatemala
  • Hong Kong
  • Hungary
  • Italy
  • Japan
  • Latvia
  • Mexico
  • Norway
  • Panama
  • Poland
  • Romania
  • Russia
  • Singapore
  • Slovenia
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • Thailand
  • Türkiye
  • Ukraine
  • United Kingdom
  • United States
Trial Identifier:

NCT02425891 2014-005490-37 WO29522

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial Summary

      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.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT02425891, WO29522, 2014-005490-37 Trial Identifier
      Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody, Nab-Paclitaxel, Placebo Treatments
      Triple Negative Breast Cancer Condition
      Official Title

      A Phase III, Multicenter, Randomized, Placebo-Controlled Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      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

      For the latest version of this information please go to www.forpatients.roche.com

       

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