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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00152178
• Other study ID #: 91023033
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: July 6, 2011
• Start date: July 1996
• Est. completion date: August 2008

Study information

• Verified date: July 2011
• Source: Taiho Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 680
• Est. completion date: August 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Taiho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Park Y, Okamura K, Mitsuyama S, Saito T, Koh J, Kyono S, Higaki K, Ogita M, Asaga T, Inaji H, Komichi H, Kohno N, Yamazaki K, Tanaka F, Ito T, Nishikawa H, Osaki A, Koyama H, Suzuki T. Uracil-tegafur and tamoxifen vs cyclophosphamide, methotrexate, fluoro — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse-free survival		recurrence and survival will be collected for 5 years after surgery	No
Secondary	Overall survival, adverse events, and the quality of life		adverse events will be collected during treatment	Yes