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

NCT00152178 | Completed Phase 3

• 1 other identifier: 91023033
• Study Type: interventional
• Target: 680
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Relapse-free survival

  recurrence and survival will be collected for 5 years after surgery

Secondary Outcomes (1)

• Overall survival, adverse events, and the quality of life

  adverse events will be collected during treatment

Study Arms (2)

1

EXPERIMENTAL

UFT (uracil, tegafur) and tamoxifen

Drug: UFT (uracil, tegafur) and tamoxifen

2

ACTIVE COMPARATOR

CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen

Drug: CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen

Interventions

UFT (uracil, tegafur) and tamoxifen DRUG

UFT(uracil, tegafur:270 mg/m2/day (p.o.) for 2 years) and tamoxifen:20 mg/body/day(p.o.) for 2 years.

1

CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen DRUG

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.

2

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Taiho Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Osaka Medical Center for Cancer and Cardiovascular Diseases

1-1-3, Nakamichi, Higashinari-ku, Osaka, Osaka, Japan

Location

Related Publications (1)

• 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. doi: 10.1038/sj.bjc.6605218. Epub 2009 Jul 28.

  PMID: 19638976 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tegafur; Uracil; Tamoxifen; Methotrexate; Fluorouracil

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Hiroki Koyama, MD

  Osaka Medical Center for Cancer and Cardiovascular Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 9, 2005
• Study Start: July 1, 1996
• Primary Completion: April 1, 2008
• Study Completion: August 1, 2008
• Last Updated: July 7, 2011

Record last verified: 2011-07

Locations

JP (1)