Adjuvant treatment of premenopausal women with endocrine-responsive early breast cancer: design of the TEXT and SOFT trials.

ABSTRACT:

Objectives

In 2003 the International Breast Cancer Study Group (IBCSG) initiated the TEXT and SOFT randomized phase III trials to answer two questions concerning adjuvant treatment for premenopausal women with endocrine-responsive early breast cancer: 1-What is the role of aromatase inhibitors (AI) for women treated with ovarian function suppression (OFS)? 2-What is the role of OFS for women who remain premenopausal and are treated with tamoxifen?

Methods

TEXT randomized patients to receive exemestane or tamoxifen with OFS. SOFT randomized patients to receive exemestane with OFS, tamoxifen with OFS, or tamoxifen alone. Treatment was for 5 years from randomization.

Results

TEXT and SOFT successfully met their enrollment goals in 2011. The 5738 enrolled women had lower-

SUBMITTER: Regan MM 

PROVIDER: S-EPMC3855346 | biostudies-literature | 2013 Dec

REPOSITORIES: biostudies-literature