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

Recruiting now · Phase 3

Conditions studied: ER-positive Breast Cancer, HER2-negative Breast Cancer, Stage IIB Breast Cancer, Stage III Breast Cancer

In brief

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.

Key facts

Study ID

NCT05512364

Run by

European Organisation for Research and Treatment of Cancer - EORTC

People needed

220

Starts

2023-12-15

Expected to finish

2035-11-01

Last updated by the study team

2026-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• ER-positive defined as ≥ 10% of cells staining positive for ER or Allred proportion score ≥3
• HER2-negative defined as a score of 0, 1+ by immunohistochemistry (IHC) or a negative in situ hybridization (ISH) based on single-probe average HER2 copy number, as per American Society of Clinical Oncology guidelines
• Intermediate to high risk of recurrence after definitive treatment for early breast cancer, defined as:
• FOR PATIENTS TREATED WITH PRIMARY SURGERY:
• Any patient with ≥ 4 positive axillary lymph nodes (stage pN2-3).
• 1-3 positive axillary lymph nodes (stage pN1) and either:
• Tumour size ≥ 5 cm or/and
• Histologic grade 3 or/and
• Ki67≥20% or/and
• High genomic risk defined as Oncotype Dx Recurrence Score >=26, Mammaprint high risk, Prosigna score >40 or EPclin risk score >=4.0.
• Negative axillary lymph nodes (stage pN0) and tumour size ≥ 2 cm and either
• Histologic grade 3 a or/and
• Ki67≥20% and/or
• High genomic risk defined as Oncotype Dx Recurrence Score >=26, Mammaprint high risk, Prosigna score >60 or EPclin risk score >=4.0. FOR PATIENTS TREATED WITH NEOADJUVANT
• SYSTEMIC TREATMENT FOLLOWED BY SURGERY:
• Patient may have received neoadjuvant endocrine therapy or neoadjuvant chemotherapy provided that:
• The initial tumour and/or the tumour after surgery meet the criteria above defined for patients treated with primary surgery or the initial tumour was staged as cT4anyN and
• There is no pathological complete response, defined as no invasive disease in the breast and axilla (ypT0/is ypN0).
• Age ≥18 years
• 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
• Previous adjuvant CDK4/6 inhibitor or PARP-inhibitor treatment is allowed provided it is completed

Where it is running

• Cliniques Universitaires Saint-Luc — Brussels, Belgium (enrolling)
• Hopital Universitaire Brugmann — Brussels, Belgium (enrolling)
• Grand Hopital de Charleroi - Site Notre Dame — Charleroi, Belgium (enrolling)
• CHU Helora Pole Hospitalier Jolimont - Hopital Jolimont — Haine-Saint-Paul, Belgium (enrolling)
• AZ Groeninge Kortrijk - Campus Kennedylaan — Kortrijk, Belgium (enrolling)
• U.Z. Leuven - Campus Gasthuisberg — Leuven, Belgium (enrolling)
• CHU Site Sainte-Elisabeth-UCL Namur — Namur, Belgium (enrolling)
• AZ Delta - Campus Rumbeke — Roeselare, Belgium (enrolling)
• Centre Hospitalier Regional Verviers — Verviers, Belgium (enrolling)
• German Oncology Center — Limassol, Cyprus (enrolling)
• Bank Of Cyprus Oncology Centre — Stróvolos, Cyprus (enrolling)
• Clinique Belharra-Ramsay Sante — Bayonne, France (enrolling)
• Centre de Radiotherapie Pierre Curie — Beuvry, France (enrolling)
• Centre Hospitalier - Boulogne Sur Mer — Boulogne-sur-Mer, France (enrolling)
• CHU de Lyon - Hopital Femme Mere Enfant — Bron, France (enrolling)
• Centre Hospitalier Dr Techer — Calais, France (enrolling)
• Societe de Recherche Oncologique Clinique 37 — Chambray-lès-Tours, France (enrolling)
• Hopital de Douai- Centre Leonard de Vinci — Dechy, France (enrolling)
• Institut de Cancerologie de Bourgogne — Dijon, France (enrolling)
• CHU de Limoges - Hopital Dupuytren — Limoges, France (enrolling)
• CHU de Lyon - Hopital De La Croix Rousse — Lyon, France (enrolling)
• CHU de Lyon - Hopital de la Croix Rousse — Lyon, France (enrolling)
• Polyclinique De Gentilly - Centre d'Oncologie — Nancy, France (enrolling)
• Institut Curie - Hopital de Paris — Paris, France (enrolling)
• Institut Jules Bordet — Anderlecht, Belgium (enrolling)

Full record on ClinicalTrials.gov

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