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CompletedNCT00152191Updated Jul 7, 2011

A Randomized Controlled Study of Postoperative Adjuvant Therapy of Uracil-tegafur (UFT) Compared With Cyclophosphamide/Methotrexate/5-fluorouracil (CMF) in Breast Cancer (NSAS-BC)

A Phase 3 interventional study of UFT (uracil, tegafur) and cyclophosphamide, methotrexate, and fluorouracil in Breast Cancer, sponsored by Taiho Pharmaceutical Co., Ltd.. Completed at 1 site in Japan. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-07-07.

Sponsored by Taiho Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,300
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Female
01

Study summary

This is a randomized controlled study designed to evaluate the relapse-free survival of the UFT group compared with the CMF group. Patients will be randomly assigned to receive either CMF or UFT within 12 weeks after curative resection. To evaluate treatment efficacy, data on recurrence, and survival will be collected for up to 10 years after enrollment of the final patient. To assess safety, data on adverse events will be collected for 2 years after the start of treatment. Patients'quality of life will be assessed by means of a questionnaire.

02

Conditions studied

  • Breast Cancer

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Keywords

  • Breast Cancer
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 1,300 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Taiho Pharmaceutical Co., Ltd. is the lead sponsor of 43 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Prior anticancer treatment
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,300 participants (estimated)

Study arms

  • Experimental
    1

    UFT (uracil, tegafur)

    Drug: UFT (uracil, tegafur)

  • Active comparator
    2

    CMF(cyclophosphamide, methotrexate, and fluorouracil)

    Drug: cyclophosphamide, methotrexate, and fluorouracil

Interventions

  • DrugUFT (uracil, tegafur)

    uracil, tegafur was orally administered by 300 mg per square meter per day for 2 years

  • Drugcyclophosphamide, methotrexate, and fluorouracil

    cyclophosphamide:100 mg, po, day 1-14 methotrexate:40 mg/m2, day 1, 8 q28 days x 6 cycles fluorouracil:500 mg/m2, day 1, 8

06

What researchers measure

Primary outcomes

  1. Relapse-free survival

    Time frame: every course for first three courses, then every other course

Secondary outcomes

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

    Time frame: any time

07

Study locations

1 site
  • National Cancer Center
    5-1-1, Tsukiji, chuo-ku, Tokyo, Japan
08

References and documents

Publications

  • Watanabe T, Sano M, Takashima S, Kitaya T, Tokuda Y, Yoshimoto M, Kohno N, Nakagami K, Iwata H, Shimozuma K, Sonoo H, Tsuda H, Sakamoto G, Ohashi Y. Oral uracil and tegafur compared with classic cyclophosphamide, methotrexate, fluorouracil as postoperative chemotherapy in patients with node-negative, high-risk breast cancer: National Surgical Adjuvant Study for Breast Cancer 01 Trial. J Clin Oncol. 2009 Mar 20;27(9):1368-74. doi: 10.1200/JCO.2008.18.3939. Epub 2009 Feb 9. PubMed 19204202 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00152191
Lead sponsor
Taiho Pharmaceutical Co., Ltd.
First posted
Sep 9, 2005
Start date
Oct 1996
Primary completion
Oct 2007
Completion
Jan 2008
Last update
Jul 7, 2011

Study contacts

Toru Watanabe, MD
principal investigator · Hamamatsu Oncology Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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