The Comparative Trial of UFT + TAM With CMF + TAM in Adjuvant Therapy for Breast Cancer (CUBC)

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: UFT (uracil, tegafur) and tamoxifen; Drug: CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen

• Registration Number: NCT00152178
• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.

Brief Summary

This controlled study is designed to evaluate the relapse-free survival of UFT + TAM compared with CMF + TAM. Patients are randomly assigned to receive either CMF + TAM or UFT + TAM within 6 weeks after surgery. To assess treatment efficacy, data on recurrence and survival will be collected for 5 years after surgery. To evaluate the safety, data on adverse events will be collected during treatment. Patients'quality of life will be assessed by means of a questionnaire.

Detailed Description

Not available

Study Timeline

• Study Start: 1996-07
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-09
• Primary Completion: 2008-04
• Study Completion: 2008-08
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-06
• Last Update Posted: 2011-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 680

Inclusion Criteria

• Age 20 to 65
• Hematopoietic WBC ≥ 4,000/mm^3 Platelet ≥ 100,000/mm^3 Hemoglobin ≥ 11.0 g/dL
• Hepatic AST and ALT ≤ 40 U/L Total bilirubin ≤ 1.5 mg/dL
• Renal BUN ≤ 25 mg/dL Creatinine ≤ 1.5 mg/dL

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	UFT (uracil, tegafur) and tamoxifen	UFT (uracil, tegafur) and tamoxifen
2	CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen	CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen

Primary Outcome Measures

Name	Time	Method
Relapse-free survival	recurrence and survival will be collected for 5 years after surgery

Secondary Outcome Measures

Name	Time	Method
Overall survival, adverse events, and the quality of life	adverse events will be collected during treatment

Trial Locations

Locations (1)

Osaka Medical Center for Cancer and Cardiovascular Diseases; 🇯🇵 1-1-3, Nakamichi, Higashinari-ku, Osaka, Osaka, Japan

Osaka Medical Center for Cancer and Cardiovascular Diseases

🇯🇵1-1-3, Nakamichi, Higashinari-ku, Osaka, Osaka, Japan