Gemcitabine and Cisplatin as First Line Combination Therapy in Patients With Triple-negative MBC
- Registration Number
- NCT00601159
- Lead Sponsor
- Fudan University
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 70
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
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description gemcitabine and cisplatin gemcitabine and cisplatin cisplatin and gemcitabine in the management of triple negative metastatic breast cancer
- Primary Outcome Measures
Name Time Method PFS (progression free survival) 1 year
- Secondary Outcome Measures
Name Time Method BRCA1 mutation realtionship with efficacy and toxicity analysis at the end of therapy side effects 6 months pharmacogenetic analysis collect blood samples before therapy
Trial Locations
- Locations (1)
Fudan University Cancer Hospital
🇨🇳Shanghai, Shanghai, China