RecruitingPhase 2NCT06923527

Circulating Tumor DNA

A Single Arm Phase II Trial of Circulating Tumor DNA-guided Adjuvant Therapy With Elacestrant in Adults With Hormone Receptor Positive HER2 Negative Breast Cancers at Risk for Late Recurrence (CATE)

Sponsor

Yale University

Enrollment

50 participants

Start Date

Sep 30, 2025

Study Type

INTERVENTIONAL

Conditions

ER+ Breast Cancer

Summary

This is a single-arm, phase II study examining elacestrant in the adjuvant treatment of patients with ER+ breast cancer who test positive for circulating tumor DNA (ctDNA) during the screening period of the trial. Our trial will proceed in three separate phases: screening, treatment, and follow-up.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a hormone-blocking pill called elacestrant to prevent breast cancer from coming back in people who had an early-stage hormone-positive (ER+), HER2-negative breast cancer 5–20 years ago. Researchers will use a blood test called ctDNA to find tiny traces of cancer DNA in the bloodstream — and only treat people whose ctDNA comes back positive. **You may be eligible if...** - You are 18 or older - You had stage IIB or III ER+/HER2- breast cancer diagnosed 5–20 years ago - You have finished hormone (endocrine) therapy and been off it for at least 4 weeks - Your ctDNA blood test comes back positive and scans show no signs of spread **You may NOT be eligible if...** - Your cancer has already spread to other parts of the body - You are currently on hormone therapy or have taken elacestrant before - You are pregnant - You are taking certain medications that interact with the study drug (strong CYP3A4 inducers/inhibitors) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGElacestrant

Administration of elacestrant will follow the FDA approved dose and schedule for patients with ER+ metastatic breast cancer. Elacestrant 345 mg will be administered orally once daily for 12 cycles or until disease progression or unacceptable toxicity. The pills shall be administered with food (to reduce nausea and vomiting) at approximately the same time each day, and the prescription will be provided with the standard "Swallow tablets whole; do not chew, crush, or split" warning label.