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HER2 Negative Breast Cancer / Elacestrant / Advanced Breast Cancer · Phase 3 Trial
ClinicalTrials.gov · August 20, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned Phase 3 randomized trial comparing elacestrant plus everolimus versus elacestrant plus placebo in ER+/HER2− ESR1-mutated advanced breast cancer resistant to prior endocrine therapy and CDK4/6 inhibitors. No results have been posted in this registry record; the study is currently recruiting and outcomes remain unknown.
Phase 3, Interventional, Randomized, Parallel, Double masking, Treatment purpose. Advanced Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer, ESR1 Gene Mutation; age from 18 Years. Intervention: Interventional Arm 1. Compared with: Control Arm 2 — Active Comparator. n = 300. 104 sites across 9 countries.
Primary outcome: progression-free survival (PFS) by blinded independent central review (BIRC) comparing elacestrant+everolimus versus elacestrant+placebo Planned enrollment: 300 participants Follow-up: until disease progression, treatment discontinuation, new anti-cancer treatment, withdrawal of consent, death, or end of study, average 12 months
This is a registry record with no results posted; no efficacy or safety data are available Follow-up: until disease progression, treatment discontinuation, new anti-cancer treatment, withdrawal of consent, death, or end of study, average 12 months
If positive results are obtained and published, this trial would address an important unmet need in heavily pretreated ER+/HER2− advanced breast cancer with ESR1 mutations. Clinicians should await peer-reviewed results before incorporation into practice.
This is a Phase 3 trial registration with no results posted; the planned design is rigorous but outcomes remain unknown and unverified.
As stated by the source record.
Quoted from the source exactly as published.
If positive results are obtained and published, this trial would address an important unmet need in heavily pretreated ER+/HER2− advanced breast cancer with ESR1 mutations. Clinicians should await peer-reviewed results before incorporation into practice.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Registry record from ClinicalTrials.gov (NCT06382948). This is a study registration, not published results. Lead sponsor: MedSIR. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 300 participants (ESTIMATED). Conditions: Advanced Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer, ESR1 Gene Mutation. Interventions: DRUG: Everolimus; DRUG: Elacestrant; DRUG: Placebo; DRUG: Auxiliary Medicinal Product - Dexamethasone; DRUG: Auxiliary Medicinal Product - Luteinizing hormone-releasing hormone (LHRH) analogues. Primary outcome measures: To demonstrate superiority of elacestrant+everolimus vs. elacestrant+placebo in prolonging PFS based on a BIRC in patients with ER[+]/HER2[-], ESR1-mutated, ABC that have previously received ET+CDK4/6i (all patients). , Until disease progression, treatment discontinuation, the start of new anti-cancer treatment, withdrawal of consent, death, or EoS, whichever occurs first, assessed through study completion, an average of 12 months.. Brief summary: 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 performed in full compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and all applicable local Good Clinical Practice (GCP) and regulations.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.