Status:

COMPLETED

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

Lead Sponsor:

Taiho Pharmaceutical Co., Ltd.

Conditions:

Breast Cancer

Eligibility:

FEMALE

20-65 years

Phase:

PHASE3

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 aft...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    July 1 1996

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    August 1 2008

    Estimated Enrollment :

    680 Patients enrolled

    Trial Details

    Trial ID

    NCT00152178

    Start Date

    July 1 1996

    End Date

    August 1 2008

    Last Update

    July 7 2011

    Active Locations (1)

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    Osaka Medical Center for Cancer and Cardiovascular Diseases

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