Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | UFT (uracil, tegafur) and tamoxifen |
|
| 2 | Active Comparator | CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relapse-free survival | recurrence and survival will be collected for 5 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival, adverse events, and the quality of life | adverse events will be collected during treatment |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hiroki Koyama, MD | Osaka Medical Center for Cancer and Cardiovascular Diseases | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka Medical Center for Cancer and Cardiovascular Diseases | 1-1-3, Nakamichi, Higashinari-ku, Osaka | Osaka | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19638976 | Result | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005641 | Tegafur |
| D014498 | Uracil |
| D013629 | Tamoxifen |
| D008727 | Methotrexate |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D013267 |
| Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |