Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA)

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.

Trial Details

NCT ID
NCT05512364
Phase
PHASE3
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Elacestrant
  • Tamoxifen
  • Letrozole 2.5mg
  • Anastrozole 1mg
  • Exemestane 25 MG
Locations (sample)
  • Anderlecht, Belgium|50.83619,4.31454
  • Brasschaat, Belgium|51.2912,4.49182
  • Brussels, Belgium|50.85045,4.34878
  • Charleroi, Belgium|50.41136,4.44448
  • Haine-Saint-Paul, Belgium|50.45544,4.1885

Key Eligibility Criteria

  • ctDNA screening phase:
  • Main inclusion criteria:
  • Female (both pre- and postmenopausal) or male patients with histologically confirmed ER positive (regardless of PR),
  • HER2 negative breast cancer, according to local pathologist:

For full eligibility, visit ClinicalTrials.gov.

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