Neoadjuvant Study of Targeting ROS1 in Combination With Endocrine Therapy in Invasive Lobular Carcinoma of the Breast (ROSALINE)

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

January 14, 2021

Primary Completion Date

January 31, 2025

Study Completion Date

January 31, 2025

Conditions
Invasive Lobular Breast CarcinomaER+ Breast CancerHER2-negative Breast Cancer
Interventions
DRUG

Entrectinib

Entrectinib is administered orally at a dose of 600 mg once a day from days 1 to 28 of a 28-day cycle for four cycles

DRUG

Letrozole

Letrozole is administered orally at a dose of 2.5 mg once a day from days 1 to day 28 of a 28 day cycle for four cycles

DRUG

Goserelin

Goserelin is administered subcutaneously at a dose of 3.6 mg at the beginning of each cycle for 4 monthly cycles to pre-menopausal women

Trial Locations (10)

1070

Institut Jules Bordet, Brussels

1090

UZ Brussel, Brussels

1200

UCL Saint-Luc, Brussels

3000

UZ Leuven, Leuven

5000

CHU Namur - Sainte Elisabeth, Namur

6000

Grand Hôpital de Charleroi, Charleroi

9000

UZ Gent, Ghent

33076

Institut Bergonié, Bordeaux

75248

Institut Curie, Paris

94805

Institut Gustave Roussy, Villejuif

Sponsors
All Listed Sponsors
collaborator

Hoffmann-La Roche

INDUSTRY

lead

Jules Bordet Institute

OTHER