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

Fudan University

Status and phase: Completed; Phase 2

Conditions: Metastatic Breast Cancer

Treatments: Drug: gemcitabine and cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00601159

200709GP

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 70 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

gemcitabine and cisplatin

Experimental group

Description:

cisplatin and gemcitabine in the management of triple negative metastatic breast cancer

Treatment:

Drug: gemcitabine and cisplatin