CSP (Comprehensive Support Project)

CSPOR

N-SAS BC 03

Phase III randomized adjuvant study of tamoxifen alone versus sequential tamoxifen and anastrozole in hormone-responsive postmenopausal breast cancer cancer patients

Study design

This is a randomized, open-label, multicenter, collaborative study.

Trial Schema

Trial schema

Objectives

  1. To determine whether postoperative adjuvant chemotherapy with tamoxifen followed by anastrozole for a total of 5 years is equivalent or superior to 5 years of continuous treatment with tamoxifen with respect to disease-free survival in postmenopausal women with hormone-sensitive breast cancer. Progression-free survival and overall survival will also be compared between the treatment groups.
  2. To compare adverse events between continuous treatment with tamoxifen and sequential treatment with tamoxifen followed by anastrozole. HRQOL, and medical cost-effectiveness will also be compared between the treatment groups.

Primary endpoints: Disease-free survival (DFS) and adverse events

Secondary endpoints: Recurrence-free survival (RFS), overall survival (OS), HRQOL, and medical cost-effectiveness

Scheduled number of patients and study period

Planned sample size: A total of 700 patients (350 per group).
Enrollment period: from November 2002 through December 2005.
Follow-up: at least 5 years (after enrollment of the last patient).

Clinical trial registration

Registered trial number: UMIN C000000056

Presentations at medical conferences

Results and adverse events
December 2008: San Antonio Breast Cancer Symposium, Poster: P1138
QOL assessment
December 2008: San Antonio Breast Cancer Symposium, Poster: P1136
Adverse events
December 2007: San Antonio Breast Cancer Symposium, Poster: P3059
QOL assessment
December 2005: San Antonio Breast Cancer Symposium, Poster: P2044
Study design
March 2003: 8th St. Gallen International Breast Cancer Conference,
Poster: P106

Medical papers

Results: Breast Cancer Res Treat 121:379–387, 2010

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