Treatment With Tucatinib in Patients With an Isolated Brain Progression of a Metastatic Breast Cancer

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

53

Participants

Timeline

Start Date

December 17, 2021

Primary Completion Date

April 30, 2025

Study Completion Date

April 30, 2026

Conditions
Metastatic Breast Cancer With a Isolated Brain Progression
Interventions
DRUG

Tucatinib

300 mg orally twice daily

DRUG

Pertuzumab

Initial loading: 840 mg Maintenance: 420 mg, 3-weekly

DRUG

Trastuzumab

"Intravenous formulation :~Initial loading: 8 mg/kg Maintenance: 6 mg/kg, 3-weekly~Subcutaneous formulation:~600 mg (fixed dose regardless of patient's body weight), 3-weekly"

DRUG

Hormone therapy

Anastrozole (1 mg/day) or letrozole (2.5 mg/day) or fulvestrant (2x250 mg at day 1 and day 15 then every 4 weeks after the first injection)

DRUG

Pertuzumab/ Trastuzumab

"Initial loading:~1200 mg Pertuzumab / 600 mg Trastuzumab (regardless of body weight)~Maintenance:~600 mg Pertuzumab / 600 mg Trastuzumab (regardless of body weight), 3-weekly"

Trial Locations (15)

72000

Clinique Victor Hugo, Le Mans

Unknown

Institut de Cancérologie de l'Ouest - Site Paul Papin, Angers

Centre Francois Baclesse, Caen

Centre Georges François Leclerc, Dijon

Centre Leon Berard, Lyon

Hôpital privé Jean Mermoz, Lyon

CRLC Val d'Aurelle, Montpellier

Centre Antoine Lacassagne, Nice

CARIO - Centre Armoricain Radiothérapie Imagerie Médicale et Oncologi, Plérin

Centre Hospitalier Annecy Genevois, Pringy

Institut Jean Godinot, Reims

Centre Henri Becquerel, Rouen

Institut Claudius Regaud, Toulouse

Centre Hospitalier Universitaire de Tours, Tours

Gustave Roussy, Villejuif

All Listed Sponsors
collaborator

Seagen Inc.

INDUSTRY

collaborator

ARCAGY/ GINECO GROUP

OTHER

lead

UNICANCER

OTHER