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

Phase 2
18 Years
75 Years
Not Enrolling
Metastatic Breast Cancer

Thank you

Trial Information

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

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.

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

- 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

- Abnormal laboratory values: hemoglobin < 8. 0g/dl, neutrophil< 1.5×109/L, platelet<

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PFS (progression free survival)

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Zhonghua Wang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University


China: Ethics Committee

Study ID:




Start Date:

September 2007

Completion Date:

September 2010

Related Keywords:

  • Metastatic Breast Cancer
  • Metastatic Breast Cancer
  • triple-negative Breast Cancer
  • cisplatin
  • chemotherapy
  • Breast Neoplasms