A Short-term Preoperative, Evaluating Activity and Safety of Elacestrant Monotherapy as Co
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 chemothe
| Condition(s) | Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: Each patient must meet all of the following inclusion criteria to be randomized in the study: 1. Aged 18 or more. 2. Signed Informed Consent Form prior to any study-specific procedure. Patients must be willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures. 3. Patients must be affiliated to a Social Security System (or equivalent). 4. Premenopausal women ensured by checking if the women were still having regular periods over the last 6 months without any hormonal treatment or hormonal contraception or if they were irregular, FSH and estradiol levels must fall within the premenopausal range according to local laboratory definition. 5. Histologically confirmed invas |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | Gustave Roussy, Cancer Campus, Grand Paris |
| Locations | Villejuif, France |
| Start date | 2025-10-06 |
| NCT ID | NCT07159451 |
| Official listing | https://clinicaltrials.gov/study/NCT07159451 |