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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Drug: gemcitabine and cisplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gemcitabine and cisplatin<br>cisplatin and gemcitabine in the management of triple negative metastatic breast cancer | Drug: gemcitabine and cisplatin<br>* Cispaltin 25mg/m2，ivgtt，D1, 2, 3 gemcitabine 1000mg/m2，ivgtt，30'，D1, 8 repeat every 3 weeks<br>* Other names: gemzar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS (progression free survival) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| side effects |  | 6 months | 
| BRCA1 mutation realtionship with efficacy and toxicity analysis |  | at the end of therapy | 
| pharmacogenetic analysis |  | collect blood samples before therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic Breast Cancer, triple-negative Breast Cancer, cisplatin, chemotherapy