RecruitingPhase 2NCT05800275

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

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


Sponsor

UNICANCER

Enrollment

30 participants

Start Date

Dec 18, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a three-drug combination — capecitabine (oral chemotherapy), tucatinib (targeted therapy), and trastuzumab (given directly into the spinal fluid) — for HER2-positive breast cancer that has spread to the lining of the brain and spinal cord (called leptomeningeal disease). **You may be eligible if:** - You are 18 or older - You have HER2-positive metastatic breast cancer (confirmed by testing) - Cancer has spread to the lining of the brain or spinal cord, confirmed by MRI or spinal fluid testing - You are in reasonably good physical condition (ECOG 0–2) - Your life expectancy is at least 2 months - You are on a stable steroid dose (if taking steroids for brain symptoms) **You may NOT be eligible if:** - Your breast cancer is HER2-negative - You have not had leptomeningeal involvement confirmed - Your general health is too poor to tolerate treatment - You are pregnant or breastfeeding - You have had recent radiation or surgery within 2 weeks before joining the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTucatinib Oral Tablet

300 mg, twice daily

DRUGCapecitabine tablets

1000 mg/m², twice daily on days 1-14 of each 21-day cycle

DRUGTrastuzumab Injection

Intrathecal by lumbar puncture or Ommaya Reservoir, 150 mg weekly


Locations(11)

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

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NCT05800275


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