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

This study has been completed.
Information provided by:
Taiho Pharmaceutical Co., Ltd. Identifier:
First received: September 7, 2005
Last updated: July 6, 2011
Last verified: July 2011
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.

Condition Intervention Phase
Breast Cancer Drug: UFT (uracil, tegafur) Drug: cyclophosphamide, methotrexate, and fluorouracil Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by Taiho Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Relapse-free survival [ Time Frame: every course for first three courses, then every other course ]

Secondary Outcome Measures:
  • Overall survival, adverse events, and the quality of life [ Time Frame: any time ]

Estimated Enrollment: 1300
Study Start Date: October 1996
Study Completion Date: January 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
UFT (uracil, tegafur)
Drug: UFT (uracil, tegafur)
uracil, tegafur was orally administered by 300 mg per square meter per day for 2 years
Active Comparator: 2
CMF(cyclophosphamide, methotrexate, and fluorouracil)
Drug: 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


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00152191

National Cancer Center
5-1-1, Tsukiji, chuo-ku, Tokyo, Japan
Sponsors and Collaborators
Taiho Pharmaceutical Co., Ltd.
Principal Investigator: Toru Watanabe, MD Hamamatsu Oncology Center
  More Information

Responsible Party: Taiho Pharmaceutical Co., Ltd. Identifier: NCT00152191     History of Changes
Other Study ID Numbers: 01023001
Study First Received: September 7, 2005
Last Updated: July 6, 2011

Keywords provided by Taiho Pharmaceutical Co., Ltd.:
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors processed this record on September 21, 2017