Condition: Breast Cancer · Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
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.
This description comes directly from the study's public registry record.
Elie El Rassy, MD · +33 01 42 11 42 11 · Elie.EL-RASSY@gustaveroussy.fr
Chloé Serhal, PhD · +33 01 42 11 42 11 · Chloe.serhal@gustaveroussy.fr
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| Gustave Roussy | Villejuif, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07159451