Clinical trial · Interventional
The Comparative Trial of UFT + TAM With CMF + TAM in Adjuvant Therapy for Breast Cancer (CUBC)
NCT00152178CI-TRIAL-00005174completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen | Drug | — | UNRESOLVED |
| UFT (uracil, tegafur) and tamoxifen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- UFT (uracil, tegafur) and tamoxifen
- interventionNames
- Drug: UFT (uracil, tegafur) and tamoxifen
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen
- interventionNames
- Drug: CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen
Primary outcomes (1)
- measure
- Relapse-free survival
- timeFrame
- recurrence and survival will be collected for 5 years after surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTPark 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