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A Randomized Open Label Multicenter Phase 3 Trial Comparing S1 Generic With Capecitabine in Patients With Metastatic Breast Cancer.


Phase 3
18 Years
75 Years
Open (Enrolling)
Female
Metastatic Breast Cancer

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Trial Information

A Randomized Open Label Multicenter Phase 3 Trial Comparing S1 Generic With Capecitabine in Patients With Metastatic Breast Cancer.


Comparing S1 generic(Tegafur,Gimeracil and Oteracil Potassium Capsules) With Capecitabine in
Patients With Metastatic Breast Cancer.


Inclusion Criteria:



- Histologically confirmed breast cancer

- Pretreated metastatic breast cancer not more than 2 lines chemotherapy

- Have not been previously treated with capecitabine,oral fluracil

- ECOG performance status of ≤ 1

- Be female and ≥ 18 and ≤ 75 years of age

- Have at least one target lesion according to the RECIST criteria 1.1

Exclusion Criteria:

- Pregnant or lactating women

- ECOG ≥ 2

- Have been treated with capecitabine

- Evidence of CNS metastasis

- History of another malignancy 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 < 10.0 g/dl, absolute neutrophil count <
1.5×10^9/L, platelet count < 100×10^9/L, serum creatinine > upper limit of normal
(ULN), serum bilirubin > ULN, ALT and AST > 5×ULN, AKP > 5×ULN

- Serious uncontrolled intercurrent infection

- Life expectancy of less than 3 months

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression free survival

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Xi-chun Hu, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan Univeristy Cancer Hospital

Authority:

China: Ethics Committee

Study ID:

Fudan BR2012-09 CBCSG010

NCT ID:

NCT01655992

Start Date:

January 2012

Completion Date:

January 2014

Related Keywords:

  • Metastatic Breast Cancer
  • capecitabine
  • Tegafur,Gimeracil and Oteracil Potassium Capsules
  • Breast Neoplasms

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