Cisplatin vs. Doxorubicin/Cyclophosphamide in BrCa

Description

This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug, which is cisplatin in this trial, to learn how well it works in treating a specific cancer. "Investigational" means that cisplatin is still being studied for use in this setting and that research doctors are trying to find out more about it-in this case, how effective cisplatin is for treating breast cancer in BRCA mutation carriers. It also means that the FDA has not yet approved cisplatin for your type of cancer. Cisplatin has been approved by the FDA for treatment of other cancers. The purpose of this study is to evaluate cisplatin, a chemotherapy drug that has been shown to be active in the treatment of women with breast cancer and a BRCA mutation. In this study, the investigators are comparing cisplatin to the standard chemotherapy, doxorubicin and cyclophosphamide ("AC") that you might receive if you did not participate in this study.

Study Start Date

October 2012

Estimated Completion Date

June 2018

Interventions

  • Drug: Cyclophosphamide
  • Drug: Cisplatin
  • Drug: Doxorubicin

Specialties

  • Obstetrics & Gynecology: Breast
  • Oncology: Breast,Pharmacology/Therapy
  • Pharmacy: Chemotherapy/Oncology,Drug Trials

MeSH Terms

  • Breast Neoplasms

Study ID

Dana-Farber Cancer Institute -- 12-258

Status

Unknown

Trial ID

NCT01670500

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

170

Sponsor

Dana-Farber Cancer Institute

Inclusion Criteria

  • Pathologic confirmation of invasive breast cancer
  • Stage: Clinical T1 > 1.5 cm, T2 or T3, N0-3, M0
  • HER2 negative
  • If tumor is ER+, it must be grade 2 or 3 or must have oncotype recurrence score > 31
  • ER and PgR status by immunohistochemistry must be known
  • Life expectancy greater than six months
  • Use of an effective means of contraception is required

Exclusion Criteria

  • Pregnant or breastfeeding
  • Prior chemotherapy at any time
  • Prior treatment for the current breast cancer, including chemotherapy, hormonal therapy, radiation or experimental therapy
  • Ipsilateral breast recurrence, unless prior treatment consisted of excision alone for DCIS or breast-conserving treatment and hormonal therapy for DCIS or invasive cancer
  • Peripheral neuropathy of any etiology that exceeds grade 1
  • Significant hearing loss
  • Renal dysfunction
  • Use of other investigational or study agents
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs
  • Uncontrolled intercurrent illness
  • Any condition that would prohibit administration of corticosteroids
  • Uncontrolled diabetes
  • Pre-existing medical condition that would represent toxicity in excess of grade 1 as measured by CTCAE
  • Known HIV positive individuals on combination antiretroviral therapy

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (17)

Study Location Distance Name Phone Email
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles None None None
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles Judy Garber MD MPH 617-632-2282 jegarber@partners.org
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
DanaFarber Cancer Institute at Faulkner Hospital - Boston, Massachusetts 5.4 miles None None None
DanaFarber Cancer Institute at Faulkner Hospital - Boston, Massachusetts 5.4 miles None None None
Women and Infants Hospital - Providence, Rhode Island 42.6 miles None None None
New Hampshire OncologyHematology - Hooksett, New Hampshire 51.2 miles None None None
Yale School of Medicine - New Haven, Connecticut 119.2 miles None None None
Memorial SloanKettering Cancer Center - NY, New York 187.1 miles None None None
Rutgers Cancer Institute of New Jersey - New Brunswick, New Jersey 217.0 miles None None None
University of Pennsylvania Abramson Cancer Center - Philadelphia, Pennsylvania 270.8 miles None None None
Johns Hopkins - Baltimore, Maryland 356.0 miles None None None
Georgetown University Medical Center - Washington D.C., District of Columbia 394.4 miles None None None
MD Anderson Cancer Center - Houston, Texas 1,609.9 miles None None None
University of Colorado Cancer Center - Aurora, Colorado 1,759.8 miles None None None
University of Colorado Cancer Center - Aurora, Colorado 1,759.8 miles Virginia Borges MD 303-724-0186 virginia.borges@ucdenver.edu

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