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A Randomized Phase 2 Non-inferiority Trial of (Z)-Endoxifen + Goserelin Versus Exemestane + Goserelin as Neoadjuvant Treatment for Premenopausal Women With ER+, HER2-, Ki-67>10% Breast Cancer and a Single Arm Phase 2 Study of (Z)-Endoxifen as Neoadjuvant Treatment for Premenopausal Women With ER+, HER2-, Ki-67 ≤ 10% Breast Cancer

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Trial Profile

A Randomized Phase 2 Non-inferiority Trial of (Z)-Endoxifen + Goserelin Versus Exemestane + Goserelin as Neoadjuvant Treatment for Premenopausal Women With ER+, HER2-, Ki-67>10% Breast Cancer and a Single Arm Phase 2 Study of (Z)-Endoxifen as Neoadjuvant Treatment for Premenopausal Women With ER+, HER2-, Ki-67 ≤ 10% Breast Cancer

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 04 Jul 2025

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At a glance

  • Drugs Endoxifen (Primary) ; Exemestane (Primary) ; Goserelin (Primary)
  • Indications Early breast cancer; HER2 negative breast cancer
  • Focus Pharmacokinetics; Therapeutic Use
  • Acronyms EVANGELINE
  • Sponsors Atossa Therapeutics

Most Recent Events

  • 30 Apr 2025 Trial design presented at the 116th Annual Meeting of the American Association for Cancer Research
  • 25 Mar 2025 Results presented in an Atossa Therapeutics media release.
  • 24 Feb 2025 Protocol was amended to the treatment arms part 2a and 2b as the primary endpoint. Part 2a includes participants with diagnostic Ki-67 >10% randomized 1:1 to a two-arm study with potential for one arm to switch regimens based on Ki-67% at Week 4. Part 2b includes study participants with a diagnostic Ki-67 <_ 10% assigned to a single arm monotherapy.

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