OncoMatch/Clinical Trials/NCT06062498
Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer
Is NCT06062498 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies elacestrant, palbociclib, abemaciclib, ribociclib for estrogen-receptor-positive breast cancer.
Treatment: elacestrant, palbociclib, abemaciclib, ribociclib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 mutation
Patients must have a confirmed ESR1 mutation.
Required: ESR1 overexpression (>10% of tumor cells demonstrate positive nuclear staining by immunohistochemistry)
ER status will be considered positive if >10% of tumor cells demonstrate positive nuclear staining by immunohistochemistry
Required: HER2 (ERBB2) negative
HER2- negative breast cancer as per the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
Disease stage
Required: Stage IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: endocrine therapy — metastatic
Patients must have received at least 2 prior endocrine therapies, including a CDK4/6 inhibitor in the metastatic disease setting.
Must have received: CDK4/6 inhibitor — metastatic
Patients must have received at least 2 prior endocrine therapies, including a CDK4/6 inhibitor in the metastatic disease setting.
Cannot have received: elacestrant (elacestrant)
Patients who have received prior elacestrant.
Cannot have received: chemotherapy
Exception: ≤ 28 days (6 weeks for nitrosureas or mitomycin C) prior to registration
Patients who have had chemotherapy or radiotherapy ≤ 28 days (6 weeks for nitrosureas or mitomycin C) prior to registration.
Cannot have received: radiation therapy
Exception: ≤ 28 days (6 weeks for nitrosureas or mitomycin C) prior to registration
Patients who have had chemotherapy or radiotherapy ≤ 28 days (6 weeks for nitrosureas or mitomycin C) prior to registration.
Lab requirements
Blood counts
Leukocytes (WBC) ≥ 3,000/mcL; ANC ≥ 1,500/mcL; Hemoglobin (Hgb) ≥ 80-100 g/dL; Platelets (PLT) ≥ 50,000/mcL
Kidney function
Cockcroft-Gault based creatinine clearance ≥ 50 mL/min
Liver function
Total serum bilirubin < 1.5 x Institutional ULN; AST (SGOT) ≤ 3 x institutional ULN (no liver metastases), 5 x institutional ULN (liver metastases present); ALT (SGPT) ≤ 3 x institutional ULN, 5 x institutional ULN (liver metastases present)
Cardiac function
NYHA Functional Classification class 2B or better
Patients must have adequate organ and bone marrow function as defined below: Leukocytes (WBC) ≥ 3,000/mcL Absolute neutrophil count (ANC) ≥ 1,500/mcL Hemoglobin (Hgb) ≥ 80-100 g/dL Platelets (PLT) ≥ 50,000/mcL Total serum bilirubin < 1.5 x Institutional upper limit of normal (ULN) AST (SGOT) ≤ 3 x institutional ULN (no liver metastases) 5 x institutional ULN (liver metastases present) ALT (SGPT) ≤ 3 x institutional ULN 5 x institutional ULN (liver metastases present) Cockcroft-Gault based creatinine clearance ≥ 50 mL/min. Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Northwestern University · Chicago, Illinois
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