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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by Fudan University
Information provided by (Responsible Party):
Xichun Hu, Fudan University Identifier:
First received: July 27, 2012
Last updated: December 23, 2014
Last verified: December 2014

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • response rate [ Time Frame: 1.5 months ] [ Designated as safety issue: Yes ]
  • overall survival [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 386
Study Start Date: January 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2015 (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
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01655992

Contact: Xichun Hu, MD, PhD 64175590 ext 5006
Contact: Chunlei Zheng, MD, PhD 64175590 ext 5009

China, Shanghai
Fudan University Cancer Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: Xichun Hu, MD,PhD    +86-21-64175590 ext 5000   
Sponsors and Collaborators
Fudan University
Principal Investigator: Xi-chun Hu, MD,PhD Fudan Univeristy Cancer Hospital
  More Information

No publications provided

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 CBCSG010
Study First Received: July 27, 2012
Last Updated: December 23, 2014
Health Authority: China: Ethics Committee

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

Additional relevant MeSH terms:
Antimetabolites, Antineoplastic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on March 03, 2015