Study on (Z)-Endoxifen for Treating Premenopausal Women with ER+/HER2- Breast Cancer

Sponsor: Atossa Therapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05607004

Provider View

This clinical trial is exploring the use of (Z)-endoxifen, a drug that blocks estrogen, as a treatment for premenopausal women with ER+/HER2- breast cancer. The study aims to see how well the drug works in slowing down cancer growth and compares it to standard treatments.

Patient Parameters

Program Overview

This study is testing (Z)-endoxifen, a drug that blocks estrogen, to see if it can help treat premenopausal women with ER+/HER2- breast cancer. The study has two parts: one to understand how the drug works in the body and another to see how effective it is in treating cancer. Researchers will measure a cancer marker called Ki-67 to see if the drug is working. Participants may continue treatment for up to 24 weeks or until surgery if the drug is effective. The study will also compare (Z)-endoxifen to standard treatments like exemestane and goserelin.

Eligibility Criteria

Inclusion Criteria

  • Premenopausal women aged 18 or older.
  • Not pregnant, breastfeeding, or planning to become pregnant in the next year.
  • Agree to use effective non-hormonal birth control during the study.
  • Have ER+/HER2- breast cancer, confirmed by specific medical guidelines.
  • Have certain stages of invasive breast cancer as defined by medical standards.
  • Have a specific grade of cancer (Nottingham Grade 1 or 2).
  • Be in good overall health with a performance status score between 0 and 2.

Exclusion Criteria

  • Have inflammatory breast cancer or cancer in both breasts (certain conditions in the other breast are allowed).
  • Have had breast cancer or other active cancers in the past two years.
  • Have uncontrolled illnesses, such as infections needing strong medications, heart problems, high blood pressure, or diabetes.
  • Have certain heart conditions or eye problems.
  • Have a history of blood clots or specific blood disorders.
  • Have poor kidney or liver function based on specific tests.
  • Have low blood cell counts or hemoglobin levels.
  • Use hormonal therapies, including birth control or hormone replacement, during the study.
  • Be allergic to study drugs or their components.
  • Be participating in another clinical trial within six months.
  • Have known metastatic disease.

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