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

NCT01120184

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Breast Cancer

Interventions: docetaxel, paclitaxel, pertuzumab, pertuzumab-placebo, trastuzumab [Herceptin]

Countries: United States, Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Canada

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (257)

Little Rock, Arkansas, United States
La Jolla, California, United States
La Jolla, California, United States
Montebello, California, United States
San Diego, California, United States
Santa Ana, California, United States
Vallejo, California, United States
New Haven, Connecticut, United States
Aventura, Florida, United States
Coral Springs, Florida, United States
Fort Myers, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Athens, Georgia, United States
Honolulu, Hawaii, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Decatur, Illinois, United States
Harvey, Illinois, United States
Maywood, Illinois, United States
Peoria, Illinois, United States
Indianapolis, Indiana, United States
Lafayette, Indiana, United States
Louisville, Kentucky, United States
Scarborough, Maine, United States
Annapolis, Maryland, United States
Boston, Massachusetts, United States
Grand Rapids, Michigan, United States
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
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