A Randomized Controlled Study of Postoperative Adjuvant Therapy of Uracil-tegafur (UFT) Compared With Cyclophosphamide/Methotrexate/5-fluorouracil (CMF) in Breast Cancer (NSAS-BC)

Breast Cancer Clinical Trial

Official title:

A Randomized Controlled Study of Postoperative Adjuvant Therapy of UFT Compared With CMF in High-risk Women With Axillary Node-negative Breast Cancer (NSAS-BC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00152191
• Other study ID #: 01023001
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2005
• Last updated: July 6, 2011
• Start date: October 1996
• Est. completion date: January 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 is a randomized controlled study designed to evaluate the relapse-free survival of the UFT group compared with the CMF group. Patients will be randomly assigned to receive either CMF or UFT within 12 weeks after curative resection. To evaluate treatment efficacy, data on recurrence, and survival will be collected for up to 10 years after enrollment of the final patient. To assess safety, data on adverse events will be collected for 2 years after the start of treatment. Patients'quality of life will be assessed by means of a questionnaire.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1300
• Est. completion date: January 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age 18 to 75

• Performance status 0 or 1 (ECOG)

• Hematopoietic WBC = 4,000/mm^3 Platelet = 100,000/mm^3

• Hepatic AST and ALT = 2.5 times upper limit of normal(ULN) Total bilirubin = ULN

• Renal Creatinine = ULN

Exclusion Criteria:

• Prior anticancer treatment

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)
uracil, tegafur was orally administered by 300 mg per square meter per day for 2 years
• cyclophosphamide, methotrexate, and fluorouracil
cyclophosphamide:100 mg, po, day 1-14 methotrexate:40 mg/m2, day 1, 8 q28 days x 6 cycles fluorouracil:500 mg/m2, day 1, 8

Locations

Country	Name	City	State
Japan	National Cancer Center	5-1-1, Tsukiji, chuo-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Taiho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Watanabe T, Sano M, Takashima S, Kitaya T, Tokuda Y, Yoshimoto M, Kohno N, Nakagami K, Iwata H, Shimozuma K, Sonoo H, Tsuda H, Sakamoto G, Ohashi Y. Oral uracil and tegafur compared with classic cyclophosphamide, methotrexate, fluorouracil as postoperativ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse-free survival		every course for first three courses, then every other course	No
Secondary	Overall survival, adverse events, and the quality of life		any time	Yes