393
Participants
Start Date
August 5, 2021
Primary Completion Date
September 30, 2025
Study Completion Date
March 31, 2028
Trastuzumab and Pertuzumab (FDC SC) and T-DM1
"Patients will receive Trastuzumab and Pertuzumab as a subcutaneous fixed-dose combination (PH FDC SC) (± ET depending on HR status) for 8 3-week cycles, on day 1 only. ET will consist of letrozole for post-menopausal women or tamoxifen ± ovarian function suppression (OFS) for pre-menopausal women administered continuously. Men will receive tamoxifen.~After completing neoadjuvant therapy, a final breast MRI will be performed 2 weeks prior to surgery. Surgery will be performed within 4 weeks after completion of the last cycle of PH FDC SC.~Adjuvant systemic therapy will start within 4 weeks from surgery. There will be three different cohorts depending on pathological report:~* Cohort A: PH FDC SC ± ET for 10 additional 3-week cycles~* Cohort B: T-DM1 ± ET for 10 cycles~* Cohort C: T-DM1 ± ET for 10 cycles, with possibility of physician's choice chemotherapy before adjuvant T-DM1."
Consorcio Hospitalario Provincial De Castelló, Castellon
Hospital Universitario Reina Sofia, Córdoba
Centro Oncológico de Galicia, A Coruña
Hospital Clínico San Carlos, Madrid
Instituto Valenciano de Oncología (IVO), Valencia
Hospital La Fe, Valencia
Hospital Universitario de Basurto, Bilbao
UMHAT Sveti Ivan Rilski EAD Department of Medical Oncology, Sofia
Praxisnetzwerk Hämatologie und intern. Onkologie, Cologne
Evangelisches Krankenhaus Bethesda, Duisburg
Kliniken Essen Mitte, Essen
Universitätsklinikum Essen Frauenklinik, Essen
Universitätsklinikum Mannheim GmbH, Manheim
Klinikum Ernst von Bergmann, Potsdam
Békés county hospital, Békés
Tolna County Balassa János Hospital, Szekszárd
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola-Malpighi, Bologna
AO Ospedale Civile Legnano, Milan
Istituto Europeo di Oncologia - NC, Milan
Ospedale San Gerardo, Monza
Azienda Ospedaliero-Universitaria di Parma, Parma
Ospedale Guglielmo da Saliceto, Piacenza
Fondazione Policlinico Universitario Agostino Gemelli, Roma
Hospital Universitari San Joan de Reus, Reus
Hospital Universitario A Coruña, A Coruña
Hospital General Universitario de Alicante, Alicante
Institut Català d' Oncologia Badalona (ICO), Badalona
Hospital Universitari Dexeus - Grupo Quirónsalud, Barcelona
VHIO Vall d'Hebron Institute of Oncology, Barcelona
Hospital Universitario Clínico San Cecilio de Granada, Granada
Complejo Hospitalario de Jaen, Jaén
Complejo Asistencial Universitario de León, León
Hospital Universitari Arnau de Vilanova de Lleida, Lleida
Hospital Quirón San Camilo- Ruber Juan Bravo, Madrid
Hospital Ramón y Cajal, Madrid
Hospital Universitario Virgen del Rocio, Seville
Hospital Universitario de Torrejón, Torrejón
Consorcio Hospital General de Valencia, Valencia
Hospital Arnau de Vilanova de Valencia, Valencia
Hospital Clinico Universitario de Valencia, Valencia
ICO L'Hospitalet - Instituto Catalán de Oncología, L'Hospitalet de Llobregat
Hoffmann-La Roche
INDUSTRY
MedSIR
OTHER