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.
Parallel
Elacestrant
Drug400mg QD orally on a continuous dosing schedule
Tamoxifen
Drug20 mg QD orally on a continuous dosing schedule
Letrozole 2.5mg
Drug2.5 mg QD orally on a continuous dosing schedule
Anastrozole 1mg
Drug1 mg QD orally on a continuous dosing schedule
Exemestane 25 MG
Drug25 mg QD orally on a continuous dosing schedule
Distant metastasis free survival (DMFS)
Distant metastasis free survival (DMFS) defined as the time from randomisation until first distant metastatic recurrence or death from any cause, whichever occurs first
Invasive disease-free survival (iDFS)
According to the STEEP criteria, it's defined as the time between the date of randomisation and the date of the first occurrence of one of the following events: loco-regional disease recurrence, distant metastasis, invasive contralateral breast cancer, invasive non-breast second cancer, or date of death from any cause
Relapse-free survival (RFS)
Relapse-free survival (RFS) rate according to the STEEP criteria, including locoregional recurrence, distant metastasis, deaths from any cause as events
Overall survival rate
Overall survival rate • Safety including but not limited to all adverse events, serious adverse events, laboratory abnormalities graded according to CTCAE version 5.0
Adverse events
Safety including but not limited to all adverse events, serious adverse events, laboratory abnormalities graded according to CTCAE version 5.0
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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