Preoperative Cisplatin in Early Stage Breast Cancer

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to find out what effects the preoperative therapy cisplatin will have on patients with early stage estrogen receptor-negative (ER-), progesterone receptor-negative (PR-), or HER-2 negative breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Beth Israel Deaconess Medical Center; Breast Cancer Research Foundation; Brigham and Women's Hospital; Massachusetts General Hospital
• Treatments: Cisplatin

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

• Absolute neutrophil count (ANC) > 1,500/mm3

• Hemoglobin > 9mm/dl

• Platelets > 100,000/mm3

• Creatinine < 1.5mg/dl

• Glucose < 200mg/dl

• Bilirubin < 1.5 x upper limit of normal (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