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

NCT05800275 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-11-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Tucatinib Oral Tablet

300 mg, twice daily

DRUG

Capecitabine tablets

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

DRUG

Trastuzumab Injection

Intrathecal by lumbar puncture or Ommaya Reservoir, 150 mg weekly

Sponsors & Collaborators

  • Seagen Inc.

    collaborator INDUSTRY

  • UNICANCER

    lead OTHER

Principal Investigators

  • Louis LARROUQUERE · Centre Léon Bérard, Lyon

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-18
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05800275 on ClinicalTrials.gov