In this clinical trial, the Sponsor plans to investigate whether patients with HR+/HER2- eBC identified during routine clinical assessments and treatments as having intermediate to high-risk (based on Oncotype DX® or similar tests and on response assessment to 2-6 weeks of preoperative ET) achieve a survival benefit from an initial 5-years use of elacestrant (with or without a CDK 4/6 inhibitor) followed by SoC ET for further 0-2.5 years in comparison to at least 5 up to 7.5 years SoC ET therapy (+/- CDK4/6 inhibitor).
Based on several studies in the metastatic setting, it is reasonable to assume that the adjuvant use of elacestrant with or without CDK 4/6 inhibitors will prevent or delay the activation of mechanisms conferring resistance to ET (e.g., ESR1 mutations).
All patients, independent from gender
Patient must be ≥18 years at diagnosis
The patient must be capable of giving informed consent and be willing and able to comply with the requirements and restrictions in this protocol and accessible for treatment and follow-up
Sign informed consent prior to any study-specific procedures.
Known hypersensitivity to any of the compounds or incorporated substances of the IMPs
Prior malignancy with a disease-free survival of <5 years, except curatively treated basalioma of the skin or pTis of the cervix uteri
Any history of invasive cancer within the last 10 years Note: adequately treated, basal or squamous-cell skin carcinoma, non-melanomatous skin cancer, curatively resected cervical cancer, and contralateral DCIS treated by mastectomy (contralateral in relation to current invasive breast cancer diagnosis) are excepted. Previous ipsilateral DCIS, irrespective of treatment, is excluded!
Patient with distant metastases of breast cancer beyond regional lymph nodes.
Parallel
Elacestrant
DrugElacestrant, a tetrahydronaphthalene compound, is a potent, selective, and orally active oestrogen receptor-α (ERα) antagonist and degrader.
Standard-of-care endocrine treatment
DrugSoC ET comprises all endocrine treatments authorized for the condition under review. The choice is made upon investigator´s discretion.
5-year invasive disease-free survival (iDFS)
iDFS after 5 years, compared between patients randomized to adjuvant elacestrant (+/-CDK4/6i) or SOC ET (+/- CDK4/6i)
5-year distant disease-free survival (dDFS)
5-year dDFS
5-year relapse-free survival (RFS)
5-year RFS
5-year DCIS disease-free survival (DFS-DCIS)
5-year DFS-DCIS
5-year invasive breast cancer-free survival (IBCFS)
5-year IBCFS
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Women's Cancer Study Group GmbH
Lead sponsor
Berlin-Chemie Menarini
Collaborator
