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

Sponsor

Taiho Pharmaceutical Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT00152178

Collaborator

(none)

680

Enrollment

Location

Arms

145

Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: UFT (uracil, tegafur) and tamoxifen Drug: CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

680 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 1996

Actual Primary Completion Date :

Apr 1, 2008

Actual Study Completion Date :

Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 UFT (uracil, tegafur) and tamoxifen	Drug: UFT (uracil, tegafur) and tamoxifen UFT(uracil, tegafur:270 mg/m2/day (p.o.) for 2 years) and tamoxifen:20 mg/body/day(p.o.) for 2 years.
Active Comparator: 2 CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen	Drug: CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen CMF 6 cycles(q28 days X 6 cycles of cyclophosphamide:65mg/m2/day(p.o.)day 1-14, methotrexate:40mg/m2(i.v.)day 1,8 and fluorouracil:500mg/m2(i.v.)day 1,8) and tamoxifen:20mg /body/day(p.o.) for 2 years.

Arm

Intervention/Treatment

Experimental: 1

UFT (uracil, tegafur) and tamoxifen

Drug: UFT (uracil, tegafur) and tamoxifen

UFT(uracil, tegafur:270 mg/m2/day (p.o.) for 2 years) and tamoxifen:20 mg/body/day(p.o.) for 2 years.

Active Comparator: 2

CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen

Drug: CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen

CMF 6 cycles(q28 days X 6 cycles of cyclophosphamide:65mg/m2/day(p.o.)day 1-14, methotrexate:40mg/m2(i.v.)day 1,8 and fluorouracil:500mg/m2(i.v.)day 1,8) and tamoxifen:20mg /body/day(p.o.) for 2 years.

Outcome Measures

Primary Outcome Measures

Relapse-free survival [recurrence and survival will be collected for 5 years after surgery]

Secondary Outcome Measures

Overall survival, adverse events, and the quality of life [adverse events will be collected during treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Osaka Medical Center for Cancer and Cardiovascular Diseases	1-1-3, Nakamichi, Higashinari-ku, Osaka	Osaka	Japan

Sponsors and Collaborators

Taiho Pharmaceutical Co., Ltd.

Investigators

Principal Investigator: Hiroki Koyama, MD, Osaka Medical Center for Cancer and Cardiovascular Diseases

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00152178

Other Study ID Numbers:

91023033

First Posted:

Sep 9, 2005

Last Update Posted:

Jul 7, 2011

Last Verified:

Jul 1, 2011

Keywords provided by , ,

Breast Cancer

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2011