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(Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer

Study acronym: EVANGELINE
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 15 to 14
    v23
  2. Study sites: 14 to 15v22
  3. Enrollment target: 214 to 87v21 Show 7 more changesShow less
    • Primary completion date: Feb 2026 to Nov 2026
    • Primary endpoints revised (3)
    • Study completion date: Sep 2026 to Apr 2027
    • Interventions: (Z)-endoxifen (Drug), exemestane (Drug), goserelin (Drug) to (Z)-endoxifen (Drug), goserelin (Drug)
    • Eligibility criteria shortened, about 58 words
    • Secondary endpoints: 32 to 26
    • Study arms: 7 to 4
  4. Study sites: 13 to 14v20
  5. Study sites: 12 to 13v19
Show 17 earlier versionsHide 17 earlier versions
  1. Study sites: 11 to 12v18
  2. Primary endpoints: 2 to 3v17 Show 4 more changesShow less
    • Enrollment target: 180 to 214
    • Study sites: 10 to 11
    • Eligibility criteria expanded, about 418 words
    • Secondary endpoints: 26 to 32
  3. Study sites: 9 to 10v16
  4. Study sites: 8 to 9v15
  5. Study sites: 6 to 8v14
  6. Study sites: 7 to 6v13
  7. Re-verified, no change to tracked fieldsv12
  8. Study sites: 6 to 7v11
  9. Re-verified, no change to tracked fieldsv10
  10. Primary completion date: Jan 2025 to Feb 2026v9 Show 6 more changesShow less
    • Enrollment target: 174 to 180
    • Study completion date: Jul 2025 to Sep 2026
    • Interventions: Z-endoxifen (Drug), exemestane (Drug), goserelin (Drug) to (Z)-endoxifen (Drug), exemestane (Drug), goserelin (Drug)
    • Secondary endpoints: 23 to 26
    • Study arms: 5 to 7
    • Eligibility criteria shortened, about 1 word
  11. Study sites: 5 to 6v8
  12. Site contacts updated at 5 of 5 sitesv7
  13. Study sites: 4 to 5v6
  14. Start date changed from estimate of Feb 2023 to Feb 14, 2023v5
  15. Start date: Jan 2023 to Feb 2023v4
  16. Start date: Nov 2022 to Jan 2023
    • Study sites: 1 to 4
    v3
  17. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This open-label research study is studying (Z)-endoxifen as a possible treatment for pre-menopausal women with ER+/HER2- breast cancer. (Z)-endoxifen belongs to a group of drugs called selective estrogen receptor modulators or "SERM", which help block estrogen from attaching to cancer cells. This study has two parts: a pharmacokinetic part and a treatment part. The PK part (how the body processes the drug) will enroll about 18 participants. All participants will take (Z)-endoxifen capsules daily. Twelve participants will be randomly assigned (50/50 chance) to take (Z)-endoxifen alone or (Z)-endoxifen with a monthly injection of goserelin a drug that temporarily stops the ovaries from making estrogen. This part will help determine the best dose of (Z)-endoxifen by measuring the drug levels in the blood and how long the body takes to remove it. The Treatment Cohort has been simplified to a single study arm (Z)-endoxifen + goserelin. Up to 20 participants will be enrolled that have a baseline Ki-67 ≤ 10% and 45 participants will be enrolled that have a baseline Ki-67\>10%. A key goal of the study is to see if (Z)-endoxifen can slow down or stop tumor growth as measured by a reduction in Ki-67 levels. Tumor tissue samples will be taken by breast biopsy after about 4 weeks of treatment to check levels of this biomarker. If the tumor shows signs of response, participants can continue treatment for up to 24 weeks or until they have surgery. Study participation is up to 6 months (24 weeks of treatment) followed by surgery and a one-month follow up visit.
Trial Details
NCT Number NCT05607004
Lead Sponsor Atossa Therapeutics, Inc.
Collaborators: InClin, Inc.
Conditions
(from sponsor)		 Breast Neoplasms, Invasive Breast Cancer, Estrogen-receptor-positive Breast Cancer, HER2-negative Breast Cancer
Related terms Breast Neoplasms
Enrollment 87 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov