Phase 3,Single Arm,Open-Label Study Evaluating Ovarian Suppression Following 3 Month Leuprolide Acetate For Injectable Suspension (TOL2506) in Combination With Endocrine Therapy in Premenopausal Subjects With Hormone-Receptor-Positive (HR+),Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
Latest Information Update: 26 Sep 2024
At a glance
- Drugs Anastrozole (Primary) ; Exemestane (Primary) ; Letrozole (Primary) ; Leuprorelin (Primary) ; Tamoxifen (Primary)
- Indications Advanced breast cancer; Early breast cancer; HER2 negative breast cancer; Male breast cancer
- Focus Registrational; Therapeutic Use
- Acronyms OVELIA
- Sponsors Tolmar
- 09 Aug 2024 Planned End Date changed from 30 Apr 2025 to 30 Apr 2026.
- 09 Aug 2024 Planned primary completion date changed from 30 Apr 2025 to 30 Apr 2026.
- 24 Feb 2023 Planned End Date changed from 30 Jun 2024 to 30 Apr 2025.