Optimizing endocrine treatment > 5 years after surgery for breast cancer patients: a registry-based randomized clinical trial

Phase 1

• Conditions: Breast cancer; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-506135-14-00
• Lead Sponsor: Region Oerebro Laen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-18
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 3832

Inclusion Criteria

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified