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Completed

NCT Number: NCT00152178

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

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.

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Key information

Conditions

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

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Osaka Medical Center for Cancer and Cardiovascular Diseases

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Relapse-free survival

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

Secondary outcomes

  1. Overall survival, adverse events, and the quality of life

    Time frame: adverse events will be collected during treatment

Sponsors and collaborators

Lead sponsor

Taiho Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
1996
Primary completion
2008
Study completion
2008
First posted
Sep 9, 2005
Registry last updated
Jul 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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