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

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

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

Details

• Lead Sponsor: Fudan University
• Treatments: Cisplatin; Gemcitabine

Criteria

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