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

This study has been completed.
Sponsor:
Information provided by:
Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00152178
First received: September 8, 2005
Last updated: July 6, 2011
Last verified: July 2011
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Comparative Trial of UFT + TAM With CMF + TAM in Adjuvant Therapy for Breast Cancer (CUBC)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Relapse-free survival [ Time Frame: recurrence and survival will be collected for 5 years after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival, adverse events, and the quality of life [ Time Frame: adverse events will be collected during treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 680
Study Start Date: July 1996
Study Completion Date: August 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00152178

Locations
Japan
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
  More Information

Publications:
Responsible Party: Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00152178     History of Changes
Other Study ID Numbers: 91023033
Study First Received: September 8, 2005
Last Updated: July 6, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Fluorouracil
Methotrexate
Tegafur
Tamoxifen
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites
Antimetabolites, Antineoplastic
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014