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

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

• 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.

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

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
      Massachusetts General Hospital, Boston,  Massachusetts,  02115,  United States; Recruiting
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02115,  United States; Recruiting

Study chairs or principal investigators

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

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