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

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)-e

Trial Details

NCT ID
NCT05607004
Phase
PHASE2
Sponsor
Atossa Therapeutics, Inc.
Status
RECRUITING
Cancer Type
ER/PR Positive (Hormone Receptor Positive) Breast Cancer
Interventions
  • (Z)-endoxifen
  • goserelin
Locations (sample)
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Los Angeles, California, United States|34.05223,-118.24368
  • Jacksonville, Florida, United States|30.33218,-81.65565
  • Chicago, Illinois, United States|41.85003,-87.65005

Key Eligibility Criteria

  • Female sex assigned at birth. Female to male transgender individuals who have not had any hormonal therapy may be considered for the trial after re…
  • Age 18 years or older
  • Not lactating, pregnant, or planning to become pregnant in the next year and agrees to take adequate steps to prevent becoming pregnant beginning a…
  • Must agree to use at least one non-hormonal highly effective method of contraception for the entire duration of study participation beginning at in…

For full eligibility, visit ClinicalTrials.gov.

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