OncoMatch/Clinical Trials/NCT07159451
A Short-term Preoperative, Evaluating Activity and Safety of Elacestrant Monotherapy as Compared to Elacestrant + Ovarian Function Suppression (LHRH Agonist) in Premenopausal Patients With Stage I-II ER+/HER2- Breast Cancer
Is NCT07159451 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Elacestrant and Leuprorelin for breast cancer.
Treatment: Elacestrant · Leuprorelin — A prospective randomized trial designed to evaluate the mean decrease in Ki67 after 4 weeks of elacestrant monotherapy and in combination with leuprorelin in patients with early-stage HR+ BC. This preoperative study will enroll consecutive patients with early stage HR+ BC who are not candidates for neoadjuvant chemotherapy but are eligible for short-term preoperative treatment with elacestrant, with or without leuprorelin, followed by breast surgery. A total of three dedicated Formalin-fixed paraffin embedded (FFPE) samples (mandatory for all patients), along with two frozen biopsy (only for participants at Gustave Roussy), are planned to be collected at the time of inclusion from the biopsy sample and from the surgical specimen. Blood samples will also be collected throughout the study.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (ER-positive tumor cells ≥ 10% ER staining)
ER-positive tumor cells ≥ 10% ER staining BC
Required: HER2 (ERBB2) negative (IHC 0-1+, or [IHC 2+ and in situ hybridization non-amplified])
HER2- according to ASCO criteria in immunohistochemistry (IHC) and/or genomic analysis (HER2 negativity is defined as IHC 0-1+, or [IHC 2+ and in situ hybridization non-amplified])
Disease stage
Required: Stage I, II
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
Any systemic therapy (e.g, chemotherapy, targeted therapy, immune-therapy) or radiotherapy for current BC before study entry
Cannot have received: radiation therapy
Any systemic therapy (e.g, chemotherapy, targeted therapy, immune-therapy) or radiotherapy for current BC before study entry
Cannot have received: LHRH agonist
Exception: over the last 6 months prior to the ICF signature
Prior treatment with LHRH-agonists over the last 6 months prior to the ICF signature
Lab requirements
Blood counts
ANC ≥ 1.0 x 10⁹/L; platelets ≥ 75 x 10⁹/L; hemoglobin ≥ 9.0 g/dL
Kidney function
eGFR ≥30 mL/min/1.73 m² or creatinine clearance ≥ 30 mL/min; creatinine clearance ≥ 30 mL/min for creatinine > 1.5x ULN
Liver function
ALT ≤ 2.5x ULN; AST ≤ 3x ULN; total bilirubin ≤ ULN or ≤ 1.5x ULN with direct bilirubin ≤ ULN in Gilbert's Syndrome
Demonstrate adequate organ function within 7 days of inclusion : 1. Absolute neutrophil count ≥ 1.0 x 10⁹/L 2. Platelet count ≥ 75 x 10⁹/L 3. Hemoglobin ≥ 9.0 g/dL 4. Estimated glomerular filtration rate ≥30 mL/min/1.73 m² or creatinine clearance calculated by Cockcroft-Gault equation ≥ 30 mL/min Creatinine clearance ≥ 30 mL/min for subject with creatinine levels > 1.5 x institutional upper limit of normal (ULN). 5. Alanine aminotransferase (ALT) ≤ 2.5x upper limit of normal (ULN). 6. Aspartate aminotransferase (AST) ≤ 3x ULN. 7. Total bilirubin ≤ ULN or total bilirubin ≤ 1.5x ULN with direct bilirubin ≤ ULN of the laboratory in subjects with documented Gilbert's Syndrome. 8. Potassium, sodium, calcium (corrected for albumin), magnesium, and phosphorus CTCAE v5.0 Grade ≤ 1.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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