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 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 p

Trial Details

NCT ID

NCT07159451

Phase

PHASE2

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Status

RECRUITING

Cancer Type

HER2 Positive Breast Cancer

Interventions

• Elacestrant
• Leuprorelin

Locations (sample)

• Villejuif, France|48.7939,2.35992

Key Eligibility Criteria

• Each patient must meet all of the following inclusion criteria to be randomized in the study:
• Aged 18 or more.
• Signed Informed Consent Form prior to any study-specific procedure. Patients must be willing and able to comply with the protocol for the duration …
• Patients must be affiliated to a Social Security System (or equivalent).

For full eligibility, visit ClinicalTrials.gov.

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