Metastatic Breast Cancer
Conditions
Keywords
Metastatic Breast Cancer, triple-negative Breast Cancer, cisplatin, chemotherapy
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.
Interventions
DRUGgemcitabine and cisplatin
Cispaltin 25mg/m2，ivgtt，D1, 2, 3 gemcitabine 1000mg/m2，ivgtt，30'，D1, 8 repeat every 3 weeks
Sponsors
Fudan University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS (progression free survival) | 1 year |
Secondary
| Measure | 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 |
Countries
China
Outcome results
None listed