Neoadjuvant Treatment of HER2 Positive Early High-risk and Locally Advanced Breast Cancer

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

650

Participants

Timeline

Start Date

September 7, 2018

Primary Completion Date

December 15, 2026

Study Completion Date

March 15, 2027

Conditions
Invasive Breast Cancer
Interventions
DRUG

Trastuzumab

Trastuzumab will be given i.v. on day 1 every 3 weeks in arms HPCT, ACy followed by HPCT and atezolizumab and in arm HPCT and atezolizumab

DRUG

Pertuzumab

Pertuzumab will be given i.v. on day 1 every 3 weeks in arms HPCT, ACy followed by HPCT and atezolizumab and in arm HPCT and atezolizumab

DRUG

Carboplatin

Carboplatin will be given i.v. on day 1 and day 8 every 3 weeks in arms HPCT, ACy followed by HPCT and atezolizumab and in arm HPCT and atezolizumab

DRUG

Paclitaxel

Paclitaxel will be given i.v. on day 1 and day 8 every 3 weeks in arms HPCT, ACy followed by HPCT and atezolizumab and in arm HPCT and atezolizumab

DRUG

Doxorubicin

Adriamycin will be delivered i.v. on day 1 every 3 weeks in arm ACy followed by HPCT for the first 3 cycles

DRUG

Cyclophosphamide

Cyclophosphamide will be given i.v. on day 1 every 3 weeks in arm ACy followed by HPCT and atezolizumab for the first 3 cycles

DRUG

Atezolizumab

Atezolizumab will be given i.v. on day 1 every 3 weeks in arm ACy followed by HPCT and atezolizumab and in arm HPCT and atezolizumab

PROCEDURE

Surgery

Breast cancer surgery (breast and axilla) either conservative or radical not later than 4 weeks from the last dose of neoadjuvant therapy in all study arms

Trial Locations (65)

1090

"Klinische Abteilung für Allgemeine Gynäkologie und Gynäkologische Onkologie - Universitätsklinik für Frauenheilkunde Medizinische Universität Wien / AKH ", Vienna

3100

Universitätsklinikum St. Pölten Klinische Abteilung für Innere Medizin, Sankt Pölten

4010

Krankenhaus der Barmherzigen Schwestern, Linz

9020

Klinikum Klagenfurt am Wörthersee Abteilung für Innede Medizin und Hämatologie und internistische Onkologie, Klagenfurt

10003

Hospital San Pedro de Alcantara, Cáceres

10113

Klinik für Gynäkologie am Campus Charité Mitte (CCM), Berlin

15009

Centro Oncologico de Galicia, A Coruña

15706

Hospital Clinico Unv. de Santiago, Santiago de Compostela

16132

IST San Martino, Genova

17475

Universitätsklinikum Greifswald, Frauenklinik, Greifswald

18012

Hospital Virgen de la Nieves, Granada

20014

Hospital de Donostia, San Sebastián

Hospital Onkologikoa, San Sebastián

20133

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

20141

Istituto Europeo di Oncologia, Milan

20160

Ospedale Luigi Sacco, Milan

21005

Hospital Juan Ramón Jimenez, Huelva

24128

Ospedale Papa Giovanni XXIII, Bergamo

27100

Fondazione Salvatore Maugeri, Pavia

28007

Hospital Gregorio Marañon, Madrid

28033

MD Anderson Cancer Center, Madrid

28040

Hospital Clinico San Carlos, Madrid

Hospital Unv. Fundación Jimenez Diaz, Madrid

28942

Hospital de Fuenlabrada, Madrid

29010

Complejo Hospitalario de Especialidades Virgen de la Victoria, Málaga

30008

Hospital General Universitario Morales Meseguer, Murcia

30177

Gynäkologisch-Onkologische Praxis, Hanover

31008

Clinica Universitaria de Navarra, Pamplona

33100

Ospedale Santa Maria della Misericordia, Udine

37007

Complejo Hospitalario de Salamanca, Salamanca

37024

Ospedale Sacro Cuore - Don Calabria, Negrar

39130

Städtisches Klinikum Magdeburg - Klinik für Allgemein - und Viszeralchirurgie, Magdeburg

41124

AO Universitaria Policlinico di Modena, Modena

42123

Arcispedale Santa Maria Nuova - A.O. Reggio Emilia, Reggio Emilia

42551

Onkologische Praxis Velbert, Velbert

44137

St Johannes Hospital, Dortmund

45004

Hospital Virgen de la Salud de Toledo, Toledo

46010

Hospital Clínico Universitario de Valencia, Valencia

46236

Department of Gynecology and Obstetrics, Marienhospital, Bottrop

47014

Istituto Scientifico Romagnolo per lo studio e la cura dei tumori, Meldola

48013

Hospital de Basurto, Bilbao

48018

Dipartimento di Oncologia Medica AUSL della Romagna, Faenza

50009

Hospital Lozano Blesa, Zaragoza

Hospital Miguel Servet, Zaragoza

56100

Azienda Ospedaliero Universitaria Pisana Ospedale S. Chiara, Pisa

58452

Marien Hospital Witten, Witten

60431

Markus Krankenhaus - Klinik für Gynäkologie und Geburtshilfe, Frankfurt

69120

NCT Nationales Zentrum für Tumorerkrankungen Gynäkologische Onkologie, Frauenklinik, Heidelberg

72100

Presidio Ospedaliero Di Summa-Perrino, Brindisi

76135

St. Marien-Klinik GmbH Frauenklinik der St. Vincentius-Kliniken gAG - Gynäkologisches Krebszentrum Karlsruhe - Brustzentrum Karlsruhe, Karlsruhe

90419

Klinikum Nürnberg Nord, Nuremberg

95615

Am Schillerhain 1-8, Marktredwitz

96450

Klinikum Coburg, Frauenklinik, Coburg

247900

Ospedale Infermi AUSL della Romagna, Rimini

01307

Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe - Universitätsklinikum Carl Gustav Carus, Dresden

07548

SRH Waldklinikum, Gera

06120

Klinik und Poliklinik für Gynäkologie am Universitätsklinikum (Saale), Halle

Unknown

Ospedale San Raffaele, Milan

00144

Istituto Nazionale Tumori - Regina Elena, Roma

03804

Hospital Virgen de Los Lirios, Alcoy

03010

Hospital General Unv. Alicante, Alicante

06007

"Hospital Infanta Cristina de Badajoz (CICAB - Centro de Investigación Clínica del Área de Salud de Badajoz)", Badajoz

08025

Hospital de la Santa Creu i Sant Pau, Barcelona

08036

Hospital Clinic Provincial, Barcelona

Hospital del Mar - IMAS

Hospital del Mar - IMAS, Barcelona

All Listed Sponsors
collaborator

Hoffmann-La Roche

INDUSTRY

lead

Fondazione Michelangelo

OTHER

NCT03595592 - Neoadjuvant Treatment of HER2 Positive Early High-risk and Locally Advanced Breast Cancer | Biotech Hunter | Biotech Hunter