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Study identifier: NCT05800275 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Capecitabine, Tucatinib, and Intrathecal Trastuzumab for Breast Cancer Patients With Leptomeningeal Disease

Condition: Leptomeningeal Metastasis · Leptomeningeal Disease · HER2-positive Metastatic Breast Cancer  ·  Sponsor: UNICANCER

PhasePhase 2
Planned participants30
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Telma ROQUE, PhD  ·  +33 (0) 1 80 50 12 92  ·  t-roque@unicancer.fr

Jérôme LEMONNIER, PhD  ·  +33 (0) 1 71 93 67 02  ·  j-lemonnier@unicancer.fr

Always discuss trial participation with your own doctor first.

Locations (11)

Institut BergoniéBordeaux, FranceWithdrawn
Centre François BaclesseCaen, FranceRecruiting
Centre Jean PerrinClermont-Ferrand, FranceRecruiting
Centre Georges-François LeclercDijon, FranceRecruiting
Centre Léon BérardLyon, FranceRecruiting
Institut régional du Cancer de MontpellierMontpellier, FranceRecruiting
Centre Antoine LacassagneNice, FranceRecruiting
Institut Jean GodinotReims, FranceRecruiting
Centre Henri BecquerelRouen, FranceRecruiting
Institut de cancérologie Strasbourg Europe - ICANSStrasbourg, FranceRecruiting
Gustave RoussyVillejuif, FranceRecruiting

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Source record: clinicaltrials.gov/study/NCT05800275