Neoadjuvant Therapy in TRIPle Negative Breast Cancer With antiPDL1

PHASE3CompletedINTERVENTIONAL
Enrollment

278

Participants

Timeline

Start Date

April 30, 2016

Primary Completion Date

January 31, 2024

Study Completion Date

January 7, 2024

Conditions
Invasive Ductal Breast Carcinoma
Interventions
DRUG

Carboplatin

Carboplatin AUC 2 will be given i.v. on day 1 and day 8 q 3 weeks for a total of 8 cycles

DRUG

Abraxane

Abraxane, 125 mg/m2 will be given i.v. on day 1 and day 8 q 3 weeks for a total of 8 cycles

DRUG

MPDL3280A

MPDL3280A, 1200 mg. will be given i.v. infusion on day 1 q 3 weeks for a total of 8 cycles

PROCEDURE

Surgery

Breast cancer surgery (breast and axilla) either conservative or radical not later than 6 weeks

DRUG

Anthra

AC or EC (adriamycin or epirubicin and cyclophosphamide) or FEC (fluorouracil, epirubicin, and cyclophosphamide) on day 1 every three weeks for 4 cycles to be delivered after surgery

Trial Locations (41)

5020

Universitätsklinik für Innere Medizin III, mit Hämatologie, internistischer Onkologie, Hämostaseologie, Infektiologie, Rheumatologie und Onkologisches Zentrum, Salzburg

6020

Brustgesundheitzentrum Tirol, Univ. Frauenklinik Innsbruck, Innsbruck

10060

Istituto per la Ricerca sul Cancro, Candiolo

14169

Frauenarzt-Zentrum-Zehlendorf, Berlin

16132

IST San Martino, Genova

20132

Ospedale San Raffaele, Milan

20133

Fondazione IRCCS Istituto nazionale dei Tumori, Milan

20141

Istituto Europeo di Oncologia, Milan

20160

Ospedale Luigi Sacco, Milan

28040

Hospital Clínico San Carlos, Madrid

28041

Hospital Universitario 12 de octubre, Madrid

28050

Hospital Universitario HM Sanchinarro, Centro Integral Oncologico Clara Campal (CIOCC), Madrid

30177

Gynäkologisch-Onkologische Praxis, Hanover

33100

Ospedale Santa Maria della Misericordia, Udine

40138

Policlinico S. Orsola Malpoghi, Bologna

42123

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

46010

Hospital Clinico Universitario de Valencia Servicio de Onco-Hematologia, Valencia

50931

Uniklinik Köln Klinik und Poliklinic für Frauenheilkunde und Geburtshilfe Brestzentrum, Cologne

50935

Brustzentrum St. Elisabeth-Krankenhaus, Cologne

58100

Istituto Toscano Tumori Ospedale Misericordia, Grosseto

59009

Hospital Miguel Servet, Zaragoza

60389

Bethanien-Krankenhaus Onkologisches Zentrum, Frankfurt

60431

Markus Krankenhaus Klinik für Gynäkologie und Geburtshilfe, Frankfurt

69120

NCT Nationales Centrum für Tumorerkrankungen, Heidelberg

80336

Interdisciplinary Oncology Center (IOZ), München

86156

Klinikum Augsburg International Patient Service, Augsburg

447891

Augusta-Kranken-Anstalt gGmbH Klinik für Hämatologie, Onkologie & Palliativmedizin, Bochum

Unknown

Cork University Hospital, Cork

Beaumont Hospital, Dublin

Mater Misericordiae University Hospital, Dublin

St. James's Hospital, Dublin

University Hospital Waterford, Waterford

Russian Cancer Research Center named after N.N.Blokhin, Moscow

Petrov Research Institute of Oncology, Department of Breast Cancer, Saint Petersburg

"Road clinical hospital of OJSC Russian Railways", Saint Petersburg

C. Christian Hospital Taiwan, Changhua

Kaohsiung Medical University Hospital, Kaohsiung City

China Medical University Hospital No.2, Taichung

National Taiwan University Hospital, Taipei

Veteran General Hospital Taipei, Taipei

08908

Hospital Duran i Reynal Institut Català d'Oncologia, L'Hospitalet de Llobregat

All Listed Sponsors
lead

Fondazione Michelangelo

OTHER

NCT02620280 - Neoadjuvant Therapy in TRIPle Negative Breast Cancer With antiPDL1 | Biotech Hunter | Biotech Hunter