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

This study is currently recruiting participants.
Verified December 2013 by Fudan University
Sponsor:
Information provided by (Responsible Party):
Xichun Hu, Fudan University
ClinicalTrials.gov Identifier:
NCT01655992
First received: July 27, 2012
Last updated: December 1, 2013
Last verified: December 2013
  Purpose

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: August 2014 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01655992

Contacts
Contact: Xichun Hu, MD, PhD 64175590 ext 5006 huxicun@gmail.com
Contact: Chunlei Zheng, MD, PhD 64175590 ext 5009 zheng_cl2006@hotmail.com

Locations
China, Shanghai
Fudan University Cancer Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: Xichun Hu, MD,PhD    +86-21-64175590 ext 5000    huxicun@gmail.com   
Sponsors and Collaborators
Fudan University
Investigators
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
ClinicalTrials.gov Identifier: NCT01655992     History of Changes
Other Study ID Numbers: Fudan BR2012-09 CBCSG010
Study First Received: July 27, 2012
Last Updated: December 1, 2013
Health Authority: China: Ethics Committee

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tegafur
Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014