NCT05645536

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

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

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Tolmar Inc. · Industry
• Sex: All
• Age: 18 Years – 51 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	TOL2506	Leuprolide Acetate for injectable suspension, 30 mg. Subcutaneous injection every 3 months
DRUG	Tamoxifen	20 mg once daily or 10 mg 2 times daily - either tablet of solution
DRUG	Letrozole tablets	One 2.5 mg tablet taken orally once daily
DRUG	Anastrozole Tablets	One 1 mg tablet taken orally once daily
DRUG	Exemestane Tablets	One 25 mg tablet taken orally once daily

Timeline

• Start date: 2022-12-28
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2022-12-09
• Last updated: 2026-01-12

Locations

47 sites across 6 countries: United States, Argentina, Brazil, India, Mexico, Puerto Rico

Regulatory

• FDA-regulated drug study