Study on ELACESTRANT for Men and Women with Advanced Estrogen Receptor Positive, HER-2 Negative Breast Cancer

Sponsor: Stemline Therapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05596409

Provider View

This clinical trial is testing the effectiveness and safety of a drug called elacestrant in patients with advanced breast cancer that is estrogen receptor positive and HER-2 negative. Participants should not have received CDK4/6 inhibitors in the metastatic setting before.

Patient Parameters

Program Overview

The study aims to evaluate how well the drug elacestrant works and how safe it is for patients with advanced breast cancer that is estrogen receptor positive (ER+) and HER-2 negative (HER2-). Participants should not have previously received CDK4/6 inhibitors for their metastatic cancer. The trial will last about 6 months, with patients being monitored for any side effects and their overall health.

Description

This Phase 2 trial is focused on testing elacestrant in patients with advanced or metastatic breast cancer that is ER+ and HER2-. Participants should have received one or two prior hormonal therapies but not CDK4/6 inhibitors in the metastatic setting.

The study includes several phases:

  • Screening Phase: Up to 28 days before starting treatment.
  • Treatment Phase: Begins on the first day of treatment and continues until the cancer progresses or treatment is stopped for other reasons.
  • Survival Follow-Up Phase: Patients will be checked every 3 months for up to 24 months after the last patient joins the study.

Patients will be monitored for any side effects for 28 days after their last treatment.

Eligibility Criteria

Inclusion Criteria

  • Must sign an informed consent form before participating.
  • Men and women aged 18 or older.
  • Women can be premenopausal, perimenopausal, or postmenopausal. Premenopausal or perimenopausal women and men must take a hormone treatment called LHRH agonist.
  • Must have ER+ and HER2- breast cancer confirmed by lab tests.
  • Cancer must have progressed during or after the most recent therapy.
  • Must have had one or two prior hormonal therapies for advanced cancer.
  • Must have at least one measurable tumor.
  • Must be in good overall health with an ECOG performance status of 0 or 1.
  • Must have adequate blood and organ function based on specific lab tests.

Exclusion Criteria

  • Active or newly diagnosed cancer spread to the brain or spinal cord.
  • Severe symptoms or complications from cancer affecting major organs.
  • Previous chemotherapy, elacestrant, or CDK4/6 inhibitors for advanced cancer.
  • Cancer relapse during the first 2 years of hormone therapy.
  • Other invasive cancers within the last 3 years, except for certain skin or bladder cancers.
  • Uncontrolled infections or significant health issues.
  • Recent major surgery or radiation therapy.
  • Difficulty taking oral medication or conditions affecting drug absorption.
  • Known allergy to elacestrant.
  • Women who are pregnant or breastfeeding.
  • Recent use of certain medications or supplements that could interfere with the study drug.
  • Any severe medical or psychiatric condition that could affect participation.

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