Neoadjuvant Chemotherapy With Nab-paclitaxel in Women With HER2-negative High-risk Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

632

Participants

Timeline

Start Date

April 30, 2013

Primary Completion Date

September 30, 2016

Study Completion Date

March 31, 2023

Conditions
Breast Cancer
Interventions
DRUG

Abraxane

Abraxane at the dosage of 125 mg/m2 will be delivered over 30 minutes on week 1, 2 and 3 followed by 1 week rest. week rest and will be repeated for 4 cycles followed by AC or EC (adriamycin or epirubicin and cyclophosphamide) on day 1 every 3 weeks for 4 cycles or FEC (fluorouracil, epirubicin, and cyclophosphamide) on day 1 every three weeks for 4 cycles

DRUG

Paclitaxel

Paclitaxel at the dosage of 90 mg/m2 diluted in 250 mL of water for injection (WFI) over 1 hour given week 1, 2 and 3 followed by 1 week rest and will be repeated for 4 cycles followed by AC or EC (adriamycin or epirubicin and cyclophosphamide) on day 1 every 3 weeks for 4 cycles or FEC (fluorouracil, epirubicin, and cyclophosphamide) on day 1 every three weeks for 4 cycles

Trial Locations (67)

500

Royal Adelaide Hospital, Adelaide

2002

Hospital Son Llàtzer Palma de Mallorca, Palma de Mallorca

3135

Eastern Health Breast Cancer Research - Maroondah Breast Clinic, Ringwood East

Eastern Health Breast Cancer Research Maroondah Breast Clinic, Ringwood East

5000

Royal Adelaide Hospital, Adelaide

6000

Mount Hospital - Breast Clinical Trials Unit, Perth

Royal Perth Hospital, Perth

8006

Peter McCallum Cancer Centre, East Melbourne

8600

Peter MacCallum Cancer Centre Department of Surgical Oncology, East Melbourne

10003

Hospital San Pedro de Alcantara, Cáceres

14004

Hospital Universitario Reina Sofía, Córdoba

14169

Frauenarzt-Zentrum-Zehlendorf, Berlin

15009

Centro Oncologico de Galicia, A Coruña

16132

IST San Martino, Genova

20014

Onkologikoa, Donostia / San Sebastian

20025

A.O. Ospedale Civile di Legnano, Legnano

20050

A.O. San Gerardo, Monza

20080

Hospital Universitario Donostia, San Sebastián

20132

Ospedale San Raffaele, Milan

20133

Fondazione IRCCS Istituto nazionale dei tumori, Milan

20160

A.O. Ospedale Luigi Sacco, Milan

20162

A.O. Ospedale Niguarda Ca' Granda, Milan

20357

Mammazentrum - Hamburg am Krankenhaus Jerusalem, Hamburg

23007

Complejo Hospitalario de Jaen, Jaén

24125

Cliniche Gavazzeni - Humanitas Gavazzeni, Bergamo

25198

Hospital Universitari Arnau de Vilanove de Lleida, Lleida

27100

Fondazione IRCCS Policlinico San Matteo, Pavia

28009

Gregorio Maraňón Hospital, Madrid

28046

Hospital La Paz, Madrid

28922

Hospital Universitario Fundacion Alcorcón, Alcorcón

30080

J.M. Morales Meseguer, Universitary Hospital Marques in los Velez, Murcia

30177

Gynäkologisch-Onkologische Praxis, Hanover

33100

Ospedale Santa Maria della Misericordia, Udine

35012

ULSS 15 Alta Padovana, Camposampiero

36100

Azienda ULSS 6 di Vicenza, Vicenza

37007

Hospital Clinico Universitario de Salamanca, Salamanca

38320

Hospital Universitario de Canarias, San Cristóbal de La Laguna

40138

Policlinico Sant'Orsola Malpighi, Bologna

41013

Hospital Virgen del Rocio, Seville

41071

Hospital Universitario Virgen Macarena, Seville

42123

Arcispedale Santa Maria Nuova, Reggio Emilia

44124

Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna, Cona

44791

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

46009

Instituto Valenciano Oncologia, Valencia

50009

Hospital Clinico Lozano Blesa, Zaragoza

Miguel Servet University Hospital, Zaragoza

50935

St.Elisabeth-Krankenhaus Brustzentrum, Cologne

60389

Agaplesion Markus Hospital - Frankfurt, Frankfurt

Bethanien-Krankenhaus Onkologisches Zentrum, Frankfurt

67346

Onkologische Schwerpunktpraxis, Speyer

80336

Interdisciplinary Oncology Center, Munich

81925

Praxis Gynäkologie Arabella, Munich

86156

Klinikum Augsburg International Patient Service, Augsburg

91054

Universitätsklinikum Erlangen - Frauenklinik - Poliklinik, Erlangen

169610

National Cancer Centre Singapore, Singapore

Unknown

NN Petrov Research Institute of Oncology, Saint Petersburg

Hospital Teresa Herrera (Chuac), A Coruña

MD Anderson Cancer Center Madrid, Madrid

Hospital Virgen de la Salud, Toledo

Hospital Clinico Universita Valencia, Valencia

08208

Corporacio Sanitaria Parc Tauli, Sabadell

08227

Consorci Sanitari de Terrassa, Terrassa

03010

Hospital General Universitario de Alicante, Alicante

05004

Hospital Nuestra Señora de Sonsoles, Ávila

08916

Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol, Badalona

08003

Hospital del Mar, Barcelona

08036

Hospital Clinic i Provencial, Barcelona

All Listed Sponsors
lead

Fondazione Michelangelo

OTHER

NCT01822314 - Neoadjuvant Chemotherapy With Nab-paclitaxel in Women With HER2-negative High-risk Breast Cancer | Biotech Hunter | Biotech Hunter