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Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study

Name: Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study — clinical trial record (NCT05645536)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusEnrolling by Invitation

PhasePhase 3

SponsorTolmar Inc.

Started2022-12-28

View on ClinicalTrials.gov ↗

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.

Amendment history 2 changes detected by DataLookout

2026-09-02

Primary completion pushed: 2028-06 → 2030-03

2026-09-02

Completion pushed: 2028-06 → 2030-03

Trial Details

NCT Number	NCT05645536
Lead Sponsor	Tolmar Inc.
Conditions	Breast Cancer
Enrollment	250 participants
Start Date	2022-12-28
Primary Completion	2030-03 (estimated)
Study Completion	2030-03 (estimated)
Updated on ClinicalTrials.gov	2026-09-01