Clinical Trial: Preoperative Cisplatin in Early Stage Breast Cancer

This study is currently recruiting patients.
Verified by Dana-Farber Cancer Institute September 2005

Sponsors and Collaborators: Dana-Farber Cancer Institute
Dana Farber Harvard Cancer Center
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Brigham and Women''''s Hospital
Breast Cancer Research Foundation
Information provided by: Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00148694

Purpose

The purpose of this study is to find out what effects the preoperative therapy cisplatin will have on patients with early stage ER-, PR-, HER-2 negative breast cancer.
Condition Intervention Phase
Breast Cancer
ER Negative Breast Cancer
PR Negative Breast Cancer
HER-2 Negative Breast Cancer
 Drug: Cisplatin
Phase II

MedlinePlus related topics:  Breast Cancer
Genetics Home Reference related topics:  breast cancer

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study

Official Title: A Phase II Trial of Cisplatin in Early Stage ER-, PR-, HER-2 Negative Breast Cancer

Further Study Details: 
Primary Outcomes: To determine the clinical response after preoperative therapy with cisplatin in ER-, PR-, HER-2 negative early breast cancer patients.
Secondary Outcomes: To determine the pathologic complete response after preoperative therapy with cisplatin in this patient population.
Expected Total Enrollment:  27

Study start: October 2004

  • Before starting treatment patients will undergo placement of a clip into the tumor bed so the surgeon can locate the site of the tumor at the time of surgery.
  • Patients will receive cisplatin intravenously once every three weeks for a total of 4 cycles or 12 weeks of treatment.
  • After completion of cisplatin, patients will undergo surgery to remove any tumor that remains and to assess the tissue to see if tumor cells remain in the breast.
  • Patients may receive a second breast MRI and biopsy 7-14 days after treatment begins to see whether we can identify tumors that will ultimately respond to cisplatin with a rapid evaluation.
  • Patients will receive study treatment for approximately 12 weeks unless unacceptable toxicity occurs. After surgery patients will receive standard adjuvant therapy based on discussion with their physician. Follow-up progress will occur for several years.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • All tumors must be ER-, PR- and HER-2 negative
  • Age > 18 years
  • ECOG performance status of less than or equal to 1
  • ANC > 1,500/mm3
  • Hemoglobin > 9mm/dl
  • Platelets > 100,000/mm3
  • Creatinine< 1.5mg/dl
  • Glucose < 200mg/dl
  • Bilirubin < 1.5 x ULN
  • SGOT < 3.0 x ULN

Exclusion Criteria:

  • Prior chemotherapy treatment
  • Pregnant or breast-feeding women
  • History of serious illness, medical or psychiatric condition requiring medical management
  • Uncontrolled infection
  • Renal dysfunction
  • Active or severe cardiovascular or pulmonary disease
  • Peripheral neuropathy of any etiology that exceeds grade 1
  • Prior history of malignancy
  • Uncontrolled diabetes

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00148694

Judy E. Garber, MD      617-632-2282    judy_garber@dfci.harvard.edu

Massachusetts
      Dana-Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States; Recruiting
Judy E. Garber, MD, MPH,  Principal Investigator

      Massachusetts General Hospital, Boston,  Massachusetts,  02115,  United States; Recruiting
Paula Ryan, MD, PhD,  Principal Investigator

      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02115,  United States; Recruiting
Nadine Tung, MD,  Principal Investigator

Study chairs or principal investigators

Judy E. Garber, MD,  Principal Investigator,  Dana-Farber Cancer Institute   

More Information

Study ID Numbers:  04-183
Last Updated:  September 7, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00148694
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13

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