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A Study of Trastuzumab-DM1 Plus Pertuzumab Versus Trastuzumab [Herceptin] Plus a Taxane in Patients With Metastatic Breast Cancer

Phase 3
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

A Study of Trastuzumab-DM1 Plus Pertuzumab Versus Trastuzumab [Herceptin] Plus a Taxane in Patients With Metastatic Breast Cancer

Inclusion Criteria:

- 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

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

- Prior trastuzumab emtansine or pertuzumab therapy

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS) based on tumor assessments performed by an Independent Review Facility (IRF)

Outcome Time Frame:

Up to approximately 48 months after study start

Safety Issue:


Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche


United States: Food and Drug Administration

Study ID:




Start Date:

July 2010

Completion Date:

April 2016

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms



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