Optimizing extended adjuvant endocrine therapy in patients with breast cancer: a registry-based randomized clinical trial

Region Oerebro Laen0 个研究点目标入组 3,832 人开始时间: 2023年7月18日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•Inclusion criteria for Cohort 1 (premenopausal women at diagnosis converted to postmenopausal): Women who were pre- or perimenopausal at diagnosis; luminal breast cancer (defined as estrogen-receptor positive >/=10%, HER2-negative disease); treated with tamoxifen for at least 80% of a 5-year period (+/- 6 months from treatment completion); no clinical signs of metastasis after 5 years tamoxifen treatment; cN+ breast cancer at diagnosis indicating the need for extended adjuvant endocrine therapy; postmenopausal status at study entry defined according to the National Comprehensive Cancer Network Guidelines; inclusion criteria for cohort 2: (postmenopausal women at diagnosis): Women who were postmenopausal at diagnosis; luminal breast cancer (defined as estrogen-receptor positive >/=10%, HER2-negative disease); treated with AI for at least 80% of a 5-year period (+/- 6 months from treatment completion); no clinical signs of metastasis after 5 years AI treatment; cN+ breast cancer at diagnosis indicating the need for extended adjuvant endocrine therapy.

•Exclusion criteria for Cohort 1: Prior invasive breast cancer diagnosis; other invasive malignancy within 5 years before or after breast cancer diagnosis; non-luminal breast cancer (defined as estrogen-receptor < 10%); patients who were unable to complete at least 80% of 5-year initial treatment with tamoxifen; uncertain menopausal status (unable to evaluate menopausal status according to aforementioned definitions); recurrent or metastatic breast cancer within or after 5-year initial treatment with tamoxifen. DCIS-only is allowed at any time before or after breast cancer diagnosis. Exclusion criteria for cohort 2: Exclusion criteria for Cohort B: Prior invasive breast cancer diagnosis; other invasive malignancy within 5 years before or after breast cancer diagnosis; non-Luminal breast cancer (defined as estrogen-receptor < 10%); patients who were unable to complete at least 80% of 5-year initial treatment with AI; recurrent or metastatic breast cancer within or after 5-year initial treatment with AI. DCIS-only is allowed at any time before or after breast cancer diagnosis; no contraindication for tamoxifen therapy.

发起方

Region Oerebro Laen