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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

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Trial Profile

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

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 26 Sep 2024

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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
  • Most Recent Events

    • 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.

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