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.
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
Any patient with ≥ 4 positive axillary lymph nodes (stage pN2-3).
Tumour size ≥ 5 cm or/and
Suspected recurrent disease or known conflicts with the inclusion and exclusion criteria for the randomised trial
Prior treatment with any SERD or investigational ER antagonist
Previous history of invasive breast cancer
Previous history of any other malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
European Organisation for Research and Treatment of Cancer - EORTC
Lead sponsor
Menarini Group
Collaborator
Natera, Inc.
Collaborator
Borstkanker Onderzoek Groep
Collaborator
Cancer Trials Ireland
Collaborator
SOLTI Breast Cancer Research Group
Collaborator
ETOP IBCSG Partners Foundation
Collaborator
SUCCESS
Collaborator
Hellenic Cooperative Oncology Group
Collaborator
Hellenic Oncology Research Group
Collaborator
Swedish Breast Cancer Group
Collaborator