CSP (Comprehensive Support Project)

CSPOR

N-SAS BC 04

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

Study design

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

Trial Schema

Trial schema

Objectives

The aim of this study is to evaluate the following variables in postmenopausal women with hormone-sensitive primary breast cancer.

  1. Five years of continuous treatment with exemestane will be compared with sequential treatment with tamoxifen followed by exemestane for a total of 5 years as postoperative adjuvant chemotherapy for hormone-sensitive, postmenopausal breast cancer. The objective is to verify effectiveness on the basis of the endpoints of disease-free survival, overall survival, and time from randomization to the development of a new primary breast cancer. These variables are in accordance with the core protocol of international, multicenter, collaborative studies performed throughout the world (TEAM trial). The results obtained for these endpoints will be comprehensively published. The core protocol is a unified protocol used in international, multicenter, collaborative studies (TEAM International). A sub-protocol will be separately designed in Japan (TEAM Japan).
  2. In the TEAM Japan sub-protocol originally drafted in Japan, secondary effects (effects on lipid metabolism, blood coagulation and fibrinolysis, and bone-related events) will be compared among a tamoxifen group, an exemestane group, and an anastrozole group. Health-related QOL (HRQOL) will also be evaluated.
  3. To establish and expand information networks enabled by the participation of general practitioners specializing in breast cancer in clinical trials. In addition, to provide education to CRCs and advise on staff placement.

Primary endpoints

  1. TEAM International (core protocol):
    Disease-free survival at 2.75 years in 2 groups
    Disease-free survival at 5 or more years in 2 groups
  2. TEAM Japan (sub-protocol): Lipid metabolism, bone mineral density

Secondary endpoints

  1. TEAM International (core protocol):
    Overall survival
    Time from randomization to the development of a new primary breast cancer
    Relative safety profile
  2. TEAM Japan (sub-protocol):
    Blood coagulation and fibrinolysis, HRQOL
    (All patients enrolled in TEAM International and TEAM Japan will be studied.)

Scheduled number of patients and study period

Planned sample size: A total of 300 patients.
Enrollment period: from October 2003 through March 2006.
Follow-up: 5 years (after enrollment of the last patient).

Clinical trial registration

Registered trial number: UMIN C000000057

Presentations at medical conferences

QOL assessment
December 2009: San Antonio Breast Cancer Symposium, Poster: P5041
Bone metabolism
December 2007: San Antonio Breast Cancer Symposium, Poster: P2085
QOL assessment
December 2007: San Antonio Breast Cancer Symposium, Poster: P2088
Lipid metabolism
December 2006: San Antonio Breast Cancer Symposium
QOL assessment
December 2006: San Antonio Breast Cancer Symposium

Medical papers

Bone turnover markers: Oncology 79:376–381, 2010
Lipid profiles: Ann Oncol (2011) doi: 10.1093/annonc/mdq707

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