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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
N/A
Open (Enrolling)
Both
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
randomization

- Prior trastuzumab emtansine or pertuzumab therapy

Type of Study:

Interventional

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:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

BO22589

NCT ID:

NCT01120184

Start Date:

July 2010

Completion Date:

April 2016

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

Hinsdale, Illinois  60521
New Britain, Connecticut  06052
Bettendorf, Iowa  52722
Alexandria, Minnesota  56308
Albany, Georgia  31701
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
Louisville, Kentucky  40207
Little Rock, Arkansas  72205-7199
Scarborough, Maine  04074
Omaha, Nebraska  68114
Hackensack, New Jersey  07601
Albuquerque, New Mexico  87131-5636
Denver, Colorado  
Baltimore, Maryland  21287
Boston, Massachusetts  
Charlotte, North Carolina  
Eugene, Oregon  
Milwaukee, Wisconsin  
Wilmington, Delaware  
Indianapolis, Indiana  
Charleston, South Carolina  
Lebanon, New Hampshire  
Honolulu, Hawaii  96813
Providence, Rhode Island  02908
Washington, District of Columbia  
Sioux Falls, South Dakota  
Bismarck, North Dakota  58501
Salt Lake City, Utah  84112
Coeur D'alene, Idaho  83814