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

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.

Trial Details

NCT ID

NCT05800275

Phase

PHASE2

Sponsor

UNICANCER

Status

RECRUITING

Cancer Type

HER2 Positive Breast Cancer

Interventions

Tucatinib Oral Tablet
Capecitabine tablets
Trastuzumab Injection

Locations (sample)

Bordeaux, France|44.84124,-0.58046
Caen, France|49.18585,-0.35912
Clermont-Ferrand, France|45.77969,3.08682
Dijon, France|47.31344,5.01391
Lyon, France|45.74906,4.84789

Key Eligibility Criteria

Patient must have signed a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give thei…
Patients ≥18 years old;
Histologically confirmed metastatic breast cancer;
Histologically confirmed HER2 positive breast cancer, with HER2 positive defined by in situ hybridization (ISH), immunohistochemistry (IHC), or flu…

For full eligibility, visit ClinicalTrials.gov.

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