drugset
drugset / Trial / NCT05645536

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

NCT05645536 ↗

Phase 3 Enrolling by invitation 250 enrolled Tolmar Inc.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2022-12-28
Primary completion
2028-06
Completion
2028-06

Drugs

EvaluationDrugModalityDoseRoute
Subject TOL2506 Unknown 30 mg Subcutaneous
Background Anastrozole Other / unclassified 1 mg Oral
Background Exemestane Small molecule 25 mg Oral
Background Letrozole Other / unclassified 2.5 mg Oral
Background Tamoxifen Small molecule 10 mg Oral
Background Tamoxifen Small molecule 20 mg Oral

Indications

breast cancer