Condition: Advanced Breast Cancer · ER-positive Breast Cancer · HER2-negative Breast Cancer · Sponsor: MedSIR
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 everolimus therapy in patients who have ER-positive/HER2-negative, ESR1-mutated, ABC progressing to endocrine therapy and cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. The efficacy of elacestrant plus everolimus combination will be determined by assessing the period from elacestrant plus everolimus (or placebo) treatment initiation until to the first occurrence of disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason, whichever occurs first, defined as progression free survival. Rigorous eligibility criteria based on specific co-morbidities and clinicopathologic features of their disease have been designed to minimize the risk of patients participating in this study. The anticipated favorable clinical benefits of elacestrant combined with everolimus are projected to outweigh the risks of this treatment. This study will be pe…
This description comes directly from the study's public registry record.
Medsir · +34932214135 · contact.trials@medsir.org
Always discuss trial participation with your own doctor first.
| Medizinische Universität Innsbruck | Innsbruck, Austria | Recruiting |
| Ordensklinikum Linz Barmherzige Schwestern | Linz, Austria | Recruiting |
| Ordination Priv.-Doz. Dr. Michael Hubalek | Schwaz, Austria | Recruiting |
| Medical University of Vienna | Vienna, Austria | Not Yet Recruiting |
| Tacchini Instituto de Pesquisa | Bento Gonçalves, Brazil | Not Yet Recruiting |
| Hospital Cachoeiro de Itapemirim | Cachoeiro de Itapemirim, Brazil | Not Yet Recruiting |
| Catarina Pesquisa Clínica - Neoplasias Litoral | Itajaí, Brazil | Not Yet Recruiting |
| UPCO - Hospital de Clinicas de Porto Alegre | Porto Alegre, Brazil | Not Yet Recruiting |
| NOB Ondina | Salvador, Brazil | Not Yet Recruiting |
| Masaryk Memorial Cancer Institute | Brno, Czechia | Recruiting |
| Multiscan Nemocnice Horovice | Hořovice, Czechia | Recruiting |
| University Hospital Olomouc | Olomouc, Czechia | Not Yet Recruiting |
+ 87 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06382948