Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i.

This trial will study a type of advanced breast cancer (ABC) defined as endocrine receptor (ER)-positive/human epidermal growth factor receptor 2(HER2)-negative and estrogen receptor 1 (ESR1)-mutated. Patients will be treated with elacestrant, a compound that acts as a selective estrogen receptor degrader, and everolimus (or placebo), a kinase inhibitor indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer. The main purpose of the study is to analyze the efficacy (to find out how effective a treatment is) of elacestrant plus e

Trial Details

NCT ID
NCT06382948
Phase
PHASE3
Sponsor
MedSIR
Status
RECRUITING
Cancer Type
HER2 Negative Breast Cancer
Interventions
  • Everolimus
  • Elacestrant
  • Placebo
  • Auxiliary Medicinal Product - Dexamethasone
  • Auxiliary Medicinal Product - Luteinizing hormone-releasing hormone (LHRH) analogues
Locations (sample)
  • Innsbruck, Austria|47.26266,11.39454
  • Linz, Austria|48.30639,14.28611
  • Schwaz, Austria|47.35169,11.71014
  • Vienna, Austria|48.20849,16.37208
  • Bento Gonçalves, Brazil|-29.17139,-51.51917

Key Eligibility Criteria

  • Patients will be included in the study only if they meet ALL of the following criteria:
  • Patient must be capable to understand the purpose of the study and have signed written informed consent form (ICF) prior to beginning specific prot…
  • Female or male patients ≥ 18 years of age at the time of signing ICF.
  • Pre- or perimenopausal women, who do not meet the criteria for post-menopausal status (defined in continuation) and men must be concurrently receiv…

For full eligibility, visit ClinicalTrials.gov.

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