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

January 21, 2018 updated by: Xichun Hu, Fudan University

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

Comparing S1 generic With Capecitabine in Patients With Metastatic Breast Cancer.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

386

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan University Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Xeloda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression free survival
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 12 months
12 months
response rate
Time Frame: 1.5 months
1.5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Xi-chun Hu, MD,PhD, Fudan Univeristy Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

July 27, 2012

First Submitted That Met QC Criteria

August 1, 2012

First Posted (Estimate)

August 2, 2012

Study Record Updates

Last Update Posted (Actual)

January 23, 2018

Last Update Submitted That Met QC Criteria

January 21, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fudan BR2012-09 CBCSG011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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