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

NCT01655992 | Terminated Phase 3

• 1 other identifier: Fudan BR2012-09 CBCSG011
• Study Type: interventional
• Target: 386
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metastatic Breast Cancer

Keywords

capecitabine; Tegafur，Gimeracil and Oteracil Potassium Capsules

Outcome Measures

Primary Outcomes (1)

• progression free survival

  6 months

Secondary Outcomes (2)

• response rate

  1.5 months

• overall survival

  12 months

Study Arms (2)

S1 generic

EXPERIMENTAL

40mg／m2 bid four weeks on two weeks off

Drug: S1 generic

capecitabine

ACTIVE COMPARATOR

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

Drug: capecitabine

Interventions

capecitabine DRUG

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

Also known as: Xeloda

capecitabine

S1 generic DRUG

40mg／m2 bid four weeks on two weeks off

Also known as: Tegafur，Gimeracil and Oteracil Potassium Capsules

S1 generic

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine; potassium oxonate

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Xi-chun Hu, MD,PhD

  Fudan Univeristy Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director of department of medical oncology

Study Record Dates

• First Submitted: July 27, 2012
• First Posted: August 2, 2012
• Study Start: January 1, 2012
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

CN (1)