Clin2
NCT05512364Possibly a fitRecruiting

Elacestrant for ER-positive, HER2-negative breast cancer with ctDNA relapse

ER-positive Breast CancerHER2-negative Breast CancerStage IIB Breast CancerStage III Breast Cancer

Treatments studied

Part of Cancer, Skin clinical trials.

This trial tests whether elacestrant can help stop or delay breast cancer coming back in people whose blood test shows “ctDNA relapse” after early breast cancer treatment. It’s meant for hormone receptor–positive, HER2-negative breast cancer patients who are already taking hormone (endocrine) therapy and have no visible spread on scans.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 3
Enrollment
220 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You have ER-positive and HER2-negative breast cancer (ER is positive on lab testing; HER2 is negative on lab testing).
  • You are a woman (pre- or post-menopause) or a man age 18 or older with early breast cancer at higher risk of recurrence.
  • You must be able to provide a usable tumor tissue sample for the ctDNA test (not a fine-needle aspirate).
  • You must have had at least 1 year and up to 7.5 years of endocrine (ET) treatment and plan to continue it during the blood-test screening period.
  • Your ctDNA blood test (Signatera, or an approved similar test) must come back positive, and scans must show no local/regional or metastatic disease.
  • You need to be well enough for treatment (ECOG performance status 0–1) and meet basic organ-function and pregnancy-test requirements (if applicable).

View the official record on ClinicalTrials.gov

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