A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)

  • Cancer
  • 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
  • Colombia
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Guatemala
  • Hungary
  • Italy
  • Japan
  • Malaysia
  • Mexico
  • New Zealand
  • North Macedonia
  • Peru
  • Philippines
  • Poland
  • Portugal
  • Romania
  • Russia
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Thailand
  • Türkiye
  • United Kingdom
  • United States
Trial Identifier:

NCT01120184 2009-017905-13 BO22589

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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 randomized, 3-arm, multicenter, phase III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab (Herceptin) plus taxane (docetaxel or paclitaxel) in participants with HER2-positive progressive or recurrent locally advanced or previously untreated metastatic breast cancer. Participants will be randomized to 1 of 3 treatment arms (Arms A, B or C). Arm A will be open-label, whereas Arms B and C will be blinded.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT01120184, BO22589, 2009-017905-13 Trial Identifier
      docetaxel, paclitaxel, pertuzumab, pertuzumab-placebo, trastuzumab [Herceptin], trastuzumab emtansine Treatments
      Breast Cancer Condition
      Official Title

      A Randomized, 3 Arm, Multicenter, Phase III Study to Evaluate the Efficacy and the Safety of T-DM1 Combined With Pertuzumab or T-DM1 Combined With Pertuzumab-Placebo (Blinded for Pertuzumab), Versus the Combination of Trastuzumab Plus Taxane, as First Line Treatment in HER2 Positive Progressive or Recurrent Locally Advanced or Metastatic Breast Cancer

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Adult participants >/=18 years of age
      • HER2-positive breast cancer
      • Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease, and be a candidate for chemotherapy. Participants with locally advanced disease must have recurrent or progressive disease, which must not be amenable to resection with curative intent.
      • Participants must have measurable and/or non-measurable disease which must be evaluable per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
      • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
      • Adequate organ function as determined by laboratory results
      Exclusion Criteria
      • History of prior (or any) chemotherapy for metastatic breast cancer or recurrent locally advanced disease
      • An interval of <6 months from the last dose of vinca-alkaloid or taxane cytotoxic chemotherapy until the time of metastatic diagnosis
      • Hormone therapy <7 days prior to randomization
      • Trastuzumab therapy and/or lapatinib (neo- or adjuvant setting) <21 days prior to randomization
      • Prior trastuzumab emtansine or pertuzumab therapy

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

       

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