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

NCT00152191 | Completed Phase 3

• 1 other identifier: 01023001
• Study Type: interventional
• Target: 1,300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Relapse-free survival

  every course for first three courses, then every other course

Secondary Outcomes (1)

• Overall survival, adverse events, and the quality of life

  any time

Study Arms (2)

1

EXPERIMENTAL

UFT (uracil, tegafur)

Drug: UFT (uracil, tegafur)

2

ACTIVE COMPARATOR

CMF(cyclophosphamide, methotrexate, and fluorouracil)

Drug: cyclophosphamide, methotrexate, and fluorouracil

Interventions

UFT (uracil, tegafur) DRUG

uracil, tegafur was orally administered by 300 mg per square meter per day for 2 years

1

cyclophosphamide, methotrexate, and fluorouracil DRUG

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

2

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Prior anticancer treatment

Sponsors & Collaborators

• Taiho Pharmaceutical Co., Ltd.: lead

Study Sites (1)

National Cancer Center

5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan

Location

Related 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 postoperative chemotherapy in patients with node-negative, high-risk breast cancer: National Surgical Adjuvant Study for Breast Cancer 01 Trial. J Clin Oncol. 2009 Mar 20;27(9):1368-74. doi: 10.1200/JCO.2008.18.3939. Epub 2009 Feb 9.

  PMID: 19204202 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tegafur; Uracil; Cyclophosphamide; Methotrexate; Fluorouracil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Toru Watanabe, MD

  Hamamatsu Oncology Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 9, 2005
• Study Start: October 1, 1996
• Primary Completion: October 1, 2007
• Study Completion: January 1, 2008
• Last Updated: July 7, 2011

Record last verified: 2011-07

Locations

JP (1)