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Brief Title: Capecitabine, Tucatinib, and Intrathecal Trastuzumab for Breast Cancer Patients With Leptomeningeal Disease
Official Title: Multicentric Single Arm Phase II Study Evaluating the Efficacy of Association of Tucatinib, Capecitabine and Intra-CSF Trastuzumab in HER2 Amplified Breast Cancer Patients With Leptomeningeal Metastases
Study ID: NCT05800275
Brief Summary: The goal of this clinical trial is to evaluate the efficacy of tucatinib and capecitabine in combination with intrathecal trastuzumab on overall survival rate at 12 months in HER2-positive metastatic breast cancer (MBC) patients with proven leptomeningeal evolution and requiring intrathecal therapy.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Institut Bergonié, Bordeaux, , France
Centre François Baclesse, Caen, , France
Centre Jean Perrin, Clermont-Ferrand, , France
Centre Georges-François Leclerc, Dijon, , France
Centre Léon Bérard, Lyon, , France
Institut régional du Cancer de Montpellier, Montpellier, , France
Centre Antoine Lacassagne, Nice, , France
Institut Jean Godinot, Reims, , France
Centre Henri Becquerel, Rouen, , France
Institut de cancérologie Strasbourg Europe - ICANS, Strasbourg, , France
Gustave Roussy, Villejuif, , France
Name: Louis LARROUQUERE
Affiliation: Centre Léon Bérard - LYON
Role: PRINCIPAL_INVESTIGATOR