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A Trial Comparing S1 Generic With Capecitabine in Metastatic Breast Cancer (MBC)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Xichun Hu, Fudan University Identifier:
First received: July 27, 2012
Last updated: January 3, 2017
Last verified: January 2017
Comparing S1 generic With Capecitabine in Patients With Metastatic Breast Cancer.

Condition Intervention Phase
Metastatic Breast Cancer
Drug: capecitabine
Drug: S1 generic
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Open Label Multicenter Phase 3 Trial Comparing S1 Generic With Capecitabine in Patients With Metastatic Breast Cancer.

Resource links provided by NLM:

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • progression free survival [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • response rate [ Time Frame: 1.5 months ]
  • overall survival [ Time Frame: 12 months ]

Estimated Enrollment: 386
Study Start Date: January 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: S1 generic
40mg/m2 bid four weeks on two weeks off
Drug: S1 generic
40mg/m2 bid four weeks on two weeks off
Other Name: Tegafur,Gimeracil and Oteracil Potassium Capsules
Active Comparator: capecitabine
2500mg/m2/day divided into twice two weeks on one week off
Drug: capecitabine
2500mg/m2/day divided into twice two weeks on one week off
Other Name: Xeloda

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

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01655992

China, Shanghai
Fudan University Cancer Hospital
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Principal Investigator: Xi-chun Hu, MD,PhD Fudan Univeristy Cancer Hospital
  More Information

Responsible Party: Xichun Hu, Vice Director of department of medical oncology, Fudan University Identifier: NCT01655992     History of Changes
Other Study ID Numbers: Fudan BR2012-09 CBCSG011
Study First Received: July 27, 2012
Last Updated: January 3, 2017

Keywords provided by Fudan University:
Tegafur,Gimeracil and Oteracil Potassium Capsules

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on April 28, 2017