OncoMatch/Clinical Trials/NCT06201234
Evaluating the Addition of Elacestrant (Oral SERD) to Olaparib (PARP-inhibitor) in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer
Is NCT06201234 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Olaparib + Elacestrant and Olaparib for hormone receptor positive her-2 negative breast cancer.
Treatment: Olaparib + Elacestrant · Olaparib — Trial design: Phase II, prospective, multi-center, randomized, open label, parallel group study in patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with gBRCA1/2 mutation, with 2:1 randomization into Arm A (olaparib + elacestrant) or arm B (olaparib). Treatment in either arm will be given until disease progression, unacceptable toxicity, withdrawal of patient´s consent to study participation, or end of study. Trial population: Patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with gBRCA1/2 mutation, with an indication for standard-of-care PARP inhibitor therapy and planned treatment with olaparib, an ECOG performance status of 0-2 and life expectancy of \> 6 months, with normal bone marrow and kidney functions and no active or newly diagnosed central nervous system (CNS) metastases or symptomatic metastatic visceral disease at risk of life-threatening complications. Interventions: Patients randomized to Arm A will receive 600 mg olaparib daily and 400 mg elacestrant daily, while patients randomized to Arm B will receive 600 mg olaparib daily. Blood tests (hematology, biochemistry) will be performed at the beginning of every cycle, and imaging for tumor assessment (chest and abdominopelvic imaging) as well as QoL assessments will be performed every three months and in case of suspicion of progression/end of study.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: BRCA1 deleterious or suspected deleterious mutation
Required: BRCA2 deleterious or suspected deleterious mutation
Disease stage
Metastatic disease required
Locally advanced or metastatic breast cancer
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: parp inhibitor
Lab requirements
Blood counts
Hemoglobin < 9 g/dL; ANC < 1500/mm³; Platelets < 100,000/mm³
Kidney function
Serum creatinine > 1.5 x ULN or estimated creatinine clearance < 50 mL/min
Liver function
ALT/SGPT and/or AST/SGOT > 3 x ULN. If the patient has liver metastases, ALT and AST should not be ≥ 5 x ULN. ALP > 2.5 x ULN. Total serum bilirubin > 1.5 x ULN (exception: patients with Gilbert's syndrome permitted up to ≤ 3 x ULN)
Cardiac function
Any of the following within 6 months prior to enrolment: myocardial infarction, severe/unstable angina, ongoing grade ≥ 2 cardiac dysrhythmias, prolonged QTcF grade ≥ 2, uncontrolled atrial fibrillation of any grade, coronary/peripheral artery bypass graft, heart failure of NYHA Class II or greater, or cerebrovascular accident including transient ischemic attack
Inadequate organ function prior to enrolment including: Hemoglobin < 9 g/dL; ANC < 1500/mm³; Platelets < 100,000/mm³; ALT/SGPT and/or AST/SGOT > 3 x ULN. If the patient has liver metastases, ALT and AST should not be ≥ 5 x ULN. ALP > 2.5 x ULN. Total serum bilirubin > 1.5 x ULN (exception: patients with Gilbert's syndrome permitted up to ≤ 3 x ULN). Serum creatinine > 1.5 x ULN or estimated creatinine clearance < 50 mL/min. Any of the following within 6 months prior to enrolment: myocardial infarction, severe/unstable angina, ongoing grade ≥ 2 cardiac dysrhythmias, prolonged QTcF grade ≥ 2, uncontrolled atrial fibrillation of any grade, coronary/peripheral artery bypass graft, heart failure of NYHA Class II or greater, or cerebrovascular accident including transient ischemic attack.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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