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

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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Cyclophosphamide Fluorouracil Methotrexate Tamoxifen Methotrexate sodium Tamoxifen citrate

U.S. FDA Resources

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:

Park Y, Okamura K, Mitsuyama S, Saito T, Koh J, Kyono S, Higaki K, Ogita M, Asaga T, Inaji H, Komichi H, Kohno N, Yamazaki K, Tanaka F, Ito T, Nishikawa H, Osaki A, Koyama H, Suzuki T. Uracil-tegafur and tamoxifen vs cyclophosphamide, methotrexate, fluorouracil, and tamoxifen in post-operative adjuvant therapy for stage I, II, or IIIA lymph node-positive breast cancer: a comparative study. Br J Cancer. 2009 Aug 18;101(4):598-604. Epub 2009 Jul 28.

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 May 19, 2013