Safety and Pharmacokinetics of Atezolizumab Combination Treatments in Participants With HER2-Positive and HER2-Negative Breast Cancer

  • Cancer
  • Breast Cancer
  • Breast Cancer HER-2 Negative
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
Country
  • United States
Trial Identifier:

NCT02605915 2015-002113-29 GO29831

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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 is a Phase Ib, open-label, two-stage study with two active regimens in each stage designed to evaluate the safety and tolerability of combination treatment with atezolizumab, trastuzumab, and pertuzumab (with and without docetaxel) or atezolizumab and trastuzumab emtansine in participants with human epidermal growth factor receptor 2 (HER2) positive metastatic breast cancer (MBC) and locally advanced early breast cancer (EBC), and atezolizumab with doxorubicin and cyclophosphamide in HER2-negative breast cancer.

      Hoffmann-La Roche Sponsor
      Phase 1 Phase
      NCT02605915,GO29831,2015-002113-29 Trial Identifier
      Atezolizumab, Carboplatin, Docetaxel, Pertuzumab, Trastuzumab, Trastuzumab emtansine, Doxorubicin, Cyclophosphamide Treatments
      HER2-Positive Metastatic Breast Cancer, HER2-Negative Metastatic Breast Cancer, Locally Advanced or Early Breast Cancer Condition
      Official Title

      A Phase Ib, Open-Label Study Evaluating the Safety and Pharmacokinetics of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Trastuzumab Emtansine or With Trastuzumab and Pertuzumab (With and Without Docetaxel) in Patients With HER2-Positive Breast Cancer and Atezolizumab With Doxorubicin and Cyclophosphamide in HER2-Negative Breast Cancer

      Eligibility Criteria

      All Gender
      ≥ 18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Histologically documented HER2-positive and HER2-negative (cohort E only) breast cancer
      • Metastatic breast cancer that is measurable (Stage 1) or early breast cancer with a primary tumor size greater than (>) 2 centimeter (cm) (Stage 2)
      • Eastern cooperative oncology group (ECOG) performed status of 0, 1 or 2; 0 or 1 (cohort E only)
      • Life expectancy of 12 or more weeks
      • Adequate hematologic and end-organ function
      • Left ventricular ejection fraction greater than or equal to (>=) 50 percentage (%); >=55% (cohort E only)
      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 (HIV)
      • Active hepatitis B or hepatitis C

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

       

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