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Breast Cancer

Trastuzumab-DM1 for Metastatic Breast Cancer - (MARIANNE)
A Study of Trastuzumab-DM1 Plus Pertuzumab Versus Trastuzumab [Herceptin] Plus a Taxane in Patients With Metastatic Breast Cancer (UW10020)
Status Conditions Phase Study ID
Closed Breast Cancer Phase III UW10020

This randomized, 3-arm, multicentre study will evaluate the efficacy and safety of trastuzumab-DM1 with pertuzumab or trastuzumab-DM1 (T-DM1) with pertuzumab-placebo, versus the combination of trastuzumab [Herceptin] plus taxane (docetaxel or paclitaxel) in patients with HER2-positive progressive or recurrent locally advanced or previously untreated metastatic breast cancer. Patients 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.

Julie R. Gralow, MD
SCCA Breast Cancer Clinical Trials Program 800-804-8824 Refer Patient
Eligibility Criteria (must meet the following to participate in this study)
  • Adult patients >/=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. Patients with locally advanced disease must have recurrent or progressive disease, which must not be amenable to resection with curative intent.
  • Patients must have measurable and/or non-measurable disease which must be evaluable per RECIST 1.1
  • ECOG Performance Status 0 or 1
  • Adequate organ function as determined by laboratory results
Exclusions (conditions that would prevent participation in this study)
  • History of prior (or any) chemotherapy for metastatic breast cancer
  • 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 <21 days prior to randomization
  • Prior trastuzumab-DM1 or pertuzumab therapy
Last Updated
May 25, 2012
See this trial at
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.