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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

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

NCT ID

NCT01655992

First Posted

July 27, 2012

Last Updated

January 21, 2018

Sponsor

Fudan University

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

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

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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