Groupe d'Etude en Oncologie du Quebec

Titre	A Phase 3 Open-label Trial of Neoadjuvant Trastuzumab Deruxtecan (T-DXd) Monotherapy or T-DXd Followed by THP Compared to ddAC-THP in Participants With High-risk HER2-positive Early-stage Breast Cancer
Protocole ID	DESTINY-Breast11
ClinicalTrials.gov ID	NCT05113251
Type(s) de cancer	Sein
Phase	Phase III
Type étude	Clinique
Médicament	Trastuzumab Deruxtecan (T-DXd) en monothérapie versus T-DXd suivi de THP versus ddAC-THP
Institution	CIUSSS DU CENTRE-OUEST-DE-L'ILE-DE-MONTREAL HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS 3755 rue de la Côte Ste. Catherine, Montréal, QC, H3T 1E2
Ville	Montréal
Investigateur(trice) principal(e)	Dr Jean-François Boileau
Coordonnateur(trice)	Gladys El Helou 514-340-8222 poste 26581
Statut	Actif en recrutement
Critètes d'éligibilité	Patients must be at least 18 years of age. Histologically documented HER2-positive early breast cancer (EBC) participants, including clinical stage at presentation (based on mammogram or breast MRI assessment): T0-4 (inclusive of inflammatory breast cancer), N1-3, M0 or ≥ T3, N0, M0 as determined by the AJCC staging system, 8th edition ECOG performance status of 0 or 1 at randomization
Critètes d'exclusion	prior history of invasive breast cancer stage IV breast cancer (determined by AJCC staging system) any primary malignancy within 3 years (except resected non-melanoma skin cancer, curatively treated in situ disease) history of DCIS (except those treated with mastectomy >5 years prior to current diagnosis) History of, or current, ILD/pneumonitis Prior systemic therapy for the treatment of breast cancer Previous treatment with anthracyclines, cyclophosphamide or taxanes for any malignancy

Groupe d'étude en oncologie du Québec