Efficacy of gemcitabine and cisplatin (GP) as first-line combination therapy in patients with triple-negative metastatic breast cancer: Preliminary results report of a phase II trial.

1100 Background: Triple-negative breast cancer (TNBC) contributes to the poor prognosis. Only a few studies have revealed that cisplatin-based therapy may be effective for this subtype of breast cancer. The objective of this study was to evaluate doublet with gemcitabine/cisplatin (GP) as first-line therapy in patients with metastatic TNBC. Methods: This is a single-institutional phase II trial. The primary endpoint was progression-free survival (PFS). Eligible subjects were aging from 18 to 75 years old, with no prior chemotherpay for MBC, with tumors negative for ER, PR, or HER2, with at least one measurable disease according to the RECIST criteria, with ECOG PS of 0-1, and with adequate organ function. Patients received 21-day cycles of gemcitabine (1,000mg/m2) on days 1, 8 and cisplatin (25 mg/m2) on days 1-3. Treatment was continued until disease progression or unacceptable toxicity or up to 8 cycles. Response rate was evaluated every six weeks. Results: As of Nov. 2009, 65 patients had been enrolled...