Overview

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

Status:
Enrolling by invitation

Trial end date:
2028-06-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 3

Details

Lead Sponsor:

Tolmar Inc.

Treatments:

Anastrozole
Exemestane
Letrozole
Tamoxifen