clinical trial · NCT05645536
Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study
Breast CancerTOL2506TamoxifenLetrozole tabletsAnastrozole TabletsExemestane Tablets
brief summary
TOL2506A (OVELIA) is a Phase 3, single arm, open-label study evaluating the effectiveness of TOL2506 in suppressing ovarian function in premenopausal women with HR+, HER2-negative breast cancer and men with HR+ breast cancer. The TOL2506A-EXT study described here is a safety extension study to assess and collect long-term data on the ongoing safety and tolerability of TOL2506 in combination with tamoxifen or an AI for up to 4 years.
started
Dec 28, 2022
primary completion
Jun 1, 2028
completion
Jun 1, 2028
last updated
Jan 12, 2026
official title
Open-label, Safety Extension Study for Subjects With HR+, HER2-Negative Breast Cancer Who Have Completed the OVarian Suppression Evaluating Subcutaneous LeuprolIde Acetate in Breast Cancer OVELIA Study
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol