A study for patients with metastatic breast cancer (MARIANNE)

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

  • Breast Cancer
Trial Status:

Completed

This trial runs in
Cities
Trial Identifier:

NCT01120184

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      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.

      F. Hoffmann- La Roche Ltd Sponsor
      Phase 3 Phase
      NCT01120184 Trial Identifier
      Docetaxel, Paclitaxel, Pertuzumab, Pertuzumab-placebo, Trastuzumab [Herceptin], Trastuzumab Emtansine Treatments
      HER2 positive metastatic breast cancer Condition
      Official Title

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

      Eligibility Criteria

      All Gender
      18 Years and over 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

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