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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00152178
First Posted: September 9, 2005
Last Update Posted: July 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Taiho Pharmaceutical Co., Ltd.
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: September 8, 2005
First Posted: September 9, 2005
Last Update Posted: July 7, 2011
Last Verified: July 2011

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Methotrexate
Fluorouracil
Tamoxifen
Tegafur
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
Antimetabolites
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Estrogen Antagonists
Hormone Antagonists