OncoMatch/Clinical Trials/NCT05512364
Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA)
Is NCT05512364 recruiting? Yes, currently enrolling (Sep 2026). This Phase 3 trial studies multiple treatments for er-positive breast cancer.
Treatment: Elacestrant · Tamoxifen · Letrozole 2.5mg · Anastrozole 1mg · Exemestane 25 MG — This is an international, multi-center, randomised, open label, superiority phase III trial of elacestrant vs standard endocrine therapy in patients with ER+/HER2- breast cancer and ctDNA relapse. During the ctDNA screening phase, patients will be tested at different timepoints to detect the presence of ctDNA in their blood. Patients who are found to be ctDNA-positive and have no evidence of distant metastasis, will be randomised 1:1 between standard endocrine treatment (the same they were receiving when tested ctDNA positive) versus elacestrant, provided they meet all eligibility criteria. After completion of the protocol treatment period, treatment will be left at the discretion of the treating physician.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Endocrine / hormonal
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression (≥10% of cells staining positive for ER or Allred proportion score ≥3)
ER-positive defined as ≥ 10% of cells staining positive for ER or Allred proportion score ≥3
Required: HER2 (ERBB2) wild-type (IHC 0, 1+ or ISH negative)
HER2-negative defined as a score of 0, 1+ by immunohistochemistry (IHC) or a negative in situ hybridization (ISH)
Required: CTDNA positive
ctDNA positive according to the Signatera ctDNA assay (main study ctDNA test) or other ctDNA assay approved for diagnostic purposes
Disease stage
Required: Stage IIB, III
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: endocrine therapy — adjuvant
Patients must have received at least 1 year and up to 7.5 years of ET and planned to continue adjuvant ET during ctDNA screening phase
Cannot have received: selective estrogen receptor degrader
Prior treatment with any SERD or investigational ER antagonist
Lab requirements
Liver function
Child-Pugh Score greater than Class A excluded
Cardiac function
No myocardial infarction, stroke, severe/unstable angina, symptomatic cardiac arrhythmia, prolonged QTcF ≥ Grade 3 (>500 msec), or heart failure ≥ Class III (NYHA) within 3 months before enrolment
Child-Pugh Score greater than Class A; cardiovascular disorders within 3 months before enrolment: myocardial infarction, stroke, severe/unstable angina, symptomatic cardiac arrhythmia, prolonged QTcF ≥ Grade 3 (>500 msec), heart failure ≥ Class III (NYHA)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05512364 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior selective estrogen receptor degrader disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Does this trial require CTDNA?
Yes, CTDNA positive is a required biomarker for enrollment.
What disease stage is eligible?
Stage IIB or III is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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