CompletedNCT00152178Updated Jul 7, 2011

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

A Phase 3 interventional study of UFT (uracil, tegafur) and tamoxifen and CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen in Breast Cancer, sponsored by Taiho Pharmaceutical Co., Ltd.. Completed at 1 site in Japan. Open to female participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-07-07.

Sponsored by Taiho Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 680
Allocation: Randomized
Ages: 20 Years to 65 Years
Sex: Female

Study 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 studied

Breast Cancer

Browse trials for

Breast Neoplasms 12,544

Keywords

Breast Cancer

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 680 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.

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Lead sponsor

Taiho Pharmaceutical Co., Ltd. is the lead sponsor of 43 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 65 Years
Sexes eligible: Female
Accepts healthy volunteers: No

Eligibility 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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 680 participants (estimated)

Study arms

Experimental
1
UFT (uracil, tegafur) and tamoxifen
Drug: UFT (uracil, tegafur) and tamoxifen
Active comparator
2
CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen
Drug: CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen

Interventions

DrugUFT (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.
DrugCMF(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.

What researchers measure

Primary outcomes

Relapse-free survival
Time frame: recurrence and survival will be collected for 5 years after surgery

Secondary outcomes

Overall survival, adverse events, and the quality of life
Time frame: adverse events will be collected during treatment

Study locations

1 site

Osaka Medical Center for Cancer and Cardiovascular Diseases
1-1-3, Nakamichi, Higashinari-ku, Osaka, Osaka, Japan

References and documents

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. doi: 10.1038/sj.bjc.6605218. Epub 2009 Jul 28. Erratum In: Br J Cancer. 2009 Sep 15;101(6):1031. PubMed 19638976 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 7, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00152178
Lead sponsor: Taiho Pharmaceutical Co., Ltd.
First posted: Sep 9, 2005
Start date: Jul 1996
Primary completion: Apr 2008
Completion: Aug 2008
Last update: Jul 7, 2011

Study contacts

Hiroki Koyama, MD

principal investigator · Osaka Medical Center for Cancer and Cardiovascular Diseases

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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