ERADICATE: Study of Elacestrant and Trastuzumab Deruxtecan for Advanced Breast Cancer Resistant to CDK4/6 Inhibitors and Hormone Therapy

Sponsor: Sarah Sammons, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07198724

Provider View

This clinical trial is testing a new combination of drugs, Elacestrant and Trastuzumab Deruxtecan, to see if they are safe and effective for patients with advanced breast cancer that has not responded to previous treatments.

Patient Parameters

Program Overview

The study aims to find out if combining Elacestrant, a drug that targets estrogen receptors, with Trastuzumab Deruxtecan, a drug that targets HER2 proteins, can help treat patients with advanced breast cancer that is resistant to CDK4/6 inhibitors and hormone therapy. The trial will involve about 65 participants and will include various tests and procedures to monitor safety and effectiveness.

Description

This study is exploring a new treatment for patients with advanced breast cancer that has not responded to previous therapies. The treatment combines two drugs: Elacestrant, which targets estrogen receptors, and Trastuzumab Deruxtecan, which targets HER2 proteins. The study is divided into two phases. Phase I will determine the safest dose of the drug combination, while Phase II will evaluate how well the treatment works. Participants will undergo various tests, including blood tests, scans, and biopsies, to monitor their health and the treatment's effects. The study is open to adults aged 18 and older who meet specific health criteria. Participants must have advanced breast cancer that is resistant to previous treatments and must be able to swallow pills and undergo biopsies. Women of childbearing potential and men must agree to use effective contraception during the study and for a period after the study ends. The study is supported by Stemline-Menarini, which provides the study drug Elacestrant.

Eligibility Criteria

Inclusion Criteria

  • Have advanced breast cancer that is hormone receptor-positive (HR+) and HER2-low or HER2-ultralow.
  • Cancer must have progressed after treatment with CDK4/6 inhibitors and hormone therapy.
  • Must have measurable cancer that can be tracked using scans.
  • Must be 18 years or older.
  • Must have good overall health and organ function.
  • Women must be postmenopausal or on hormone therapy to suppress ovarian function.
  • Must agree to use effective contraception during and after the study.
  • Must be able to swallow pills and undergo biopsies.
  • Must provide informed consent to participate.

Exclusion Criteria

  • Have received prior treatment with similar drugs in the metastatic setting.
  • Have symptomatic brain metastases requiring treatment.
  • Have received another investigational drug within two weeks of starting the study.
  • Have a history of severe allergic reactions to similar drugs.
  • Have a history of lung inflammation requiring steroids.
  • Are pregnant or breastfeeding.
  • Have active infections like tuberculosis or hepatitis.
  • Have uncontrolled health conditions like heart disease or diabetes.
  • Have had another cancer within the past three years, except for certain non-threatening cancers.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.