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

Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01655992
• Other study ID #: Fudan BR2012-09 CBCSG011
• Status: Terminated
• Phase: Phase 3
• First received: July 27, 2012
• Last updated: January 21, 2018
• Start date: January 2012
• Est. completion date: October 2017

Study information

• Verified date: January 2018
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 386
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• capecitabine
2500mg/m2/day divided into twice two weeks on one week off
• S1 generic
40mg/m2 bid four weeks on two weeks off

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival		6 months
Secondary	response rate		1.5 months
Secondary	overall survival		12 months