Gemcitabine and Cisplatin as First Line Combination Therapy in Patients With Triple-negative MBC

Phase Ⅱ Study of Gemcitabine and Cisplatin as First Line Combination Therapy in Patients With Triple-negative MBC

Primary objective of this study is to evaluate the efficacy of gemcitabine and cisplatin as first line therapy in patients with triple-negative MBC. 80 patients will be treated into this study.

Triple-negative breast tumors could contribute to the poor prognosis comparing with luminal A breast cancer.Fewer study has revealed that Cisplatin-based therapy may be effective for this type breast cancer.

Inclusion Criteria:

• Give written informed consent prior to study, with understanding that the patient has the right to withdraw from the study at any time without prejudice
• Be female and ≥18 and ≤75 years of age
• Be ambulatory and have ECOG performance stastus of ≤1
• Have histological confirmed breast cancer,and the speciman confirmed ER negative,PR negatiev, and HER-2 negative by immunochemistry technich of Fudan cancer hospital.
• Locally advanced or metastastic breast cancer who didn't receive first-line chemotherapy. No matter whether the patient has received anthracyclin or taxane treatment as neo-adjuvant or adjuvant treatment.
• Have at least one target lesion according to the RECIST criteria.

Exclusion criteria:

• Preganant or lactating women
• Advaced patient has received one or more chemotherapies
• Chemotherapy within four weeks preceding treatment start
• ECOG ≥ 2
• Radiotherapy to the axial skeleton within the 4 weeks preceding study treatment start or insufficient recovery from the effects of prior radiotherapy
• Participation in any investigational drug study within 4 weeks preceeding treatment start
• Evidence of CNS metastasis
• History of another malignacy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix or a contralateral breast cancer
• Abnormal laboratory values: hemoglobin < 8. 0g/dl, neutrophil< 1.5×109/L, platelet< 100×109/L.
• serum creatine > upper limit of normal (ULN)
• serum bilirubin > ULN
• ALT and AST >5×ULN
• AKP >5×ULN
• Serious uncontrolled intercurrence infection
• Life expectancy of less than 3 months