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

Primary Purpose

Metastatic Breast Cancer

Status
Terminated
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
capecitabine
S1 generic
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring capecitabine, Tegafur,Gimeracil and Oteracil Potassium Capsules

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Fudan University Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

S1 generic

capecitabine

Arm Description

40mg/m2 bid four weeks on two weeks off

2500mg/m2/day divided into twice two weeks on one week off

Outcomes

Primary Outcome Measures

progression free survival

Secondary Outcome Measures

response rate
overall survival

Full Information

First Posted
July 27, 2012
Last Updated
January 21, 2018
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT01655992
Brief Title
A Trial Comparing S1 Generic With Capecitabine in Metastatic Breast Cancer (MBC)
Official Title
A Randomized Open Label Multicenter Phase 3 Trial Comparing S1 Generic With Capecitabine in Patients With Metastatic Breast Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
The sponsor decided to stop the study.
Study Start Date
January 2012 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
Keywords
capecitabine, Tegafur,Gimeracil and Oteracil Potassium Capsules

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
386 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
S1 generic
Arm Type
Experimental
Arm Description
40mg/m2 bid four weeks on two weeks off
Arm Title
capecitabine
Arm Type
Active Comparator
Arm Description
2500mg/m2/day divided into twice two weeks on one week off
Intervention Type
Drug
Intervention Name(s)
capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
2500mg/m2/day divided into twice two weeks on one week off
Intervention Type
Drug
Intervention Name(s)
S1 generic
Other Intervention Name(s)
Tegafur,Gimeracil and Oteracil Potassium Capsules
Intervention Description
40mg/m2 bid four weeks on two weeks off
Primary Outcome Measure Information:
Title
progression free survival
Time Frame
6 months
Secondary Outcome Measure Information:
Title
response rate
Time Frame
1.5 months
Title
overall survival
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xi-chun Hu, MD,PhD
Organizational Affiliation
Fudan Univeristy Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

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

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