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Her2/neu Negative Breast Cancer / Estrogen Receptor Positive Breast Cancer / Advanced Breast Cancerv · Phase 2 Trial
ClinicalTrials.gov · September 4, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned Phase 2 trial comparing elacestrant monotherapy against elacestrant plus a CDK4/6 inhibitor in ER+/HER2− advanced or metastatic breast cancer, with progression-free survival as the primary outcome over 5 years. No results are posted in this registry record; the study is actively recruiting and remains preliminary.
Phase 2, Interventional, Randomized, Single Group, Open label, Treatment purpose. Estrogen-receptor-positive Breast Cancer, HER2/Neu-Negative Breast Cancer, Advanced Breast Cancerv, Metastatic Breast Cancer; age from 18 Years. Intervention: Elacestrant Monotherapy; Combination Therapy. Compared with: Elacestrant monotherapy. n = 174. 3 sites: United States.
This is a planned Phase 2 trial comparing elacestrant monotherapy against elacestrant plus a CDK4/6 inhibitor in ER+/HER2− advanced or metastatic breast cancer, with progression-free survival as the primary outcome over 5 years. No results are posted in this registry record; the study is actively recruiting and remains preliminary.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
Results from this trial could inform whether combination therapy with elacestrant and CDK4/6 inhibitors offers clinical benefit over single-agent elacestrant in treatment-experienced patients; however, no evidence is yet available to guide practice.
This is a Phase 2 interventional trial still recruiting with no results posted; it represents early-stage hypothesis testing in a defined patient population.
As stated by the source record.
Quoted from the source exactly as published.
Results from this trial could inform whether combination therapy with elacestrant and CDK4/6 inhibitors offers clinical benefit over single-agent elacestrant in treatment-experienced patients; however, no evidence is yet available to guide 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.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06062498). This is a study registration, not published results. Lead sponsor: Northwestern University. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 174 participants (ESTIMATED). Conditions: Estrogen-receptor-positive Breast Cancer, HER2/Neu-Negative Breast Cancer, Advanced Breast Cancerv, Metastatic Breast Cancer. Interventions: DRUG: elacestrant, palbociclib, abemaciclib, ribociclib. Primary outcome measures: Progression-Free Survival (PFS) , Up to 5 years. Brief summary: Breast cancer is not only the leading cause of cancer in women, but also the leading cause of cancer deaths in women. Estrogen receptor-positive and HER2-negative breast cancer is the most prevalent breast cancer subtype. Endocrine therapy is the mainstay of treatment; however, due to the varied nature of the disease, development of resistance to this therapeutic approach is very common in the metastatic setting. The purpose of this study is to see whether the effectiveness of elacestrant can be enhanced by combining it with a targeted agent such as a CDK4/6 inhibitor to treat patients with ER+/HER2- or metastatic breast cancer with prior exposure to a CDK4/6 inhibitor.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.