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

Sponsored by:	Taiho Pharmaceutical Co., Ltd.
Information provided by:	Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00152178

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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 Uracil Tamoxifen Tegafur 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
Estimated Study Completion Date:	July 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Active Comparator 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
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

No publications provided

Responsible Party:	Taiho Pharmaceutical Co., Ltd. ( Taiho Pharmaceutical Co., Ltd. )
Study ID Numbers:	91023033
Study First Received:	September 8, 2005
Last Updated:	January 16, 2009
ClinicalTrials.gov Identifier:	NCT00152178 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Taiho Pharmaceutical Co., Ltd.:

Breast Cancer

Study placed in the following topic categories:

Antimetabolites
Immunologic Factors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Folate
Bone Density Conservation Agents
Cyclophosphamide
Selective Estrogen Receptor Modulators
Hormones
Vitamin B9
Estrogen Receptor Modulators
Methotrexate
Alkylating Agents
Breast Diseases
Estrogen Antagonists

Estrogens
Skin Diseases
Antineoplastic Agents, Hormonal
Tegafur
Adjuvants, Immunologic
Breast Neoplasms
Folinic Acid
Folic Acid Antagonists
Immunosuppressive Agents
Tamoxifen
Folic Acid
Fluorouracil
Antineoplastic Agents, Alkylating
Antirheumatic Agents

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents
Cyclophosphamide
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Neoplasms by Site
Therapeutic Uses

Abortifacient Agents
Methotrexate
Dermatologic Agents
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Breast Diseases
Estrogen Antagonists
Antineoplastic Agents, Hormonal
Skin Diseases
Breast Neoplasms
Enzyme Inhibitors
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Tamoxifen

ClinicalTrials.gov processed this record on August 30, 2009