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

PHASE2RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

December 18, 2023

Primary Completion Date

December 31, 2026

Study Completion Date

June 30, 2027

Conditions
Leptomeningeal MetastasisLeptomeningeal DiseaseHER2-positive Metastatic Breast Cancer
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

Trial Locations (11)

7600

RECRUITING

Centre Henri Becquerel, Rouen

14000

RECRUITING

Centre François Baclesse, Caen

21000

RECRUITING

Centre Georges-François Leclerc, Dijon

33000

NOT_YET_RECRUITING

Institut Bergonié, Bordeaux

34298

RECRUITING

Institut régional du Cancer de Montpellier, Montpellier

51100

RECRUITING

Institut Jean Godinot, Reims

63011

RECRUITING

Centre Jean Perrin, Clermont-Ferrand

67200

RECRUITING

Institut de cancérologie Strasbourg Europe - ICANS, Strasbourg

69008

RECRUITING

Centre Léon Bérard, Lyon

94805

RECRUITING

Gustave Roussy, Villejuif

06189

RECRUITING

Centre Antoine Lacassagne, Nice

All Listed Sponsors
collaborator

Seagen Inc.

INDUSTRY

lead

UNICANCER

OTHER