RecruitingPhase 2NCT07159451

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

A Short-term Preoperative, Window-of-opportunity Study, 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

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Enrollment

140 participants

Start Date

Oct 6, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests elacestrant — a newer oral hormone-blocking drug — given before surgery in pre-menopausal women with early-stage hormone receptor-positive, HER2-negative breast cancer. One group takes elacestrant alone; the other takes it with an ovarian-suppressing injection. The goal is to see how the cancer responds before surgery. **You may be eligible if...** - You are 18 or older and pre-menopausal (still having regular periods) - You have Stage I or II hormone receptor-positive, HER2-negative breast cancer confirmed by biopsy - Your tumor has moderate cell growth rate (Ki67 between 10–30%) - You are scheduled for surgery **You may NOT be eligible if...** - You have already gone through menopause - You have HER2-positive breast cancer - You have metastatic or Stage III/IV disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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