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A Randomized Controlled Study of Postoperative Adjuvant Therapy of UFT Compared With CMF in High-risk Women With Axillary Node-negative Breast Cancer (NSAS-BC)


Phase 3
18 Years
75 Years
Not Enrolling
Female
Breast Cancer

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Trial Information

A Randomized Controlled Study of Postoperative Adjuvant Therapy of UFT Compared With CMF in High-risk Women With Axillary Node-negative Breast Cancer (NSAS-BC)


Inclusion Criteria:



- Age 18 to 75

- Performance status 0 or 1 (ECOG)

- Hematopoietic WBC ≥ 4,000/mm^3 Platelet ≥ 100,000/mm^3

- Hepatic AST and ALT ≤ 2.5 times upper limit of normal(ULN) Total bilirubin ≤ ULN

- Renal Creatinine ≤ ULN

Exclusion Criteria:

- Prior anticancer treatment

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Relapse-free survival

Outcome Time Frame:

every course for first three courses, then every other course

Safety Issue:

No

Principal Investigator

Toru Watanabe, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hamamatsu Oncology Center

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

01023001

NCT ID:

NCT00152191

Start Date:

October 1996

Completion Date:

January 2008

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Breast Neoplasms

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