Phase III to Evaluate Patient´s Preference of Subcutaneous Trastuzumab vs Intravenous in HER2+ Advanced Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

166

Participants

Timeline

Start Date

September 18, 2013

Primary Completion Date

November 30, 2016

Study Completion Date

April 30, 2018

Conditions
Breast Cancer
Interventions
DRUG

Trastuzumab Injectable Solution

Subcutaneous injection vial with a fixed dose of trastuzumab (600mg) and recombinant human hyaluronidase (10.000U) identical to that provided by the device. 3 weeks x 2 cycles.

DRUG

Trastuzumab Injectable Product

Single injection device is provided and loaded with the mixture of trastuzumab (600mg) and recombinant human hyaluronidase (10.000U) and is ready for use. 3 weeks x 2 cycles

DRUG

Trastuzumab Injection

Powder for concentrate for solution for infusion. 1 cycle

Trial Locations (27)

10600

Hospital Virgen del Puerto de Plasencia, Plasencia

18014

Hospital Universitario Virgen de las Nieves, Granada

25198

Hospital Universitario Arnau de Vilanova de Lleida, Lleida

27004

Hospital Universitario Lucus Augusti, Lugo

28006

Hospital Universitario La Princesa, Madrid

28007

Hospital General Universitario Gregorio Marañón, Madrid

28021

Hospital Universitario 12 de Octubre, Madrid

28223

Hospital Univesitario Quirón Madrid, Pozuelo de Alarcón

28911

Hospital Universitario Severo Ochoa, Leganés

28924

Hospital Universitario de Fuenlabrada, Fuenlabrada

29603

Hospital Costa del Sol, Marbella

30202

Hospital Universitario Santa Lucía, Cartagena

37007

Hospital Universitario de Salamanca, Salamanca

41009

Hospital Universitario Virgen de la Macarena, Seville

41013

Hospital Universitario Virgen del Rocío, Seville

43201

Hospital Universitario San Joan de Reus, Reus

45004

Hospital Virgen de la Salud, Toledo

46010

Hospital Clínico Universitario de Valencia, Valencia

50009

Hospital Universitario Miguel Servet, Zaragoza

07500

Hospital de Manacor, Manacor

08402

Hospital General Universitario de Granollers, Granollers

08304

Hospital de Mataró, Mataró

08970

Hospital Sant Joan Despí Moises Broggi, Sant Joan Despí

05004

Hospital Nuestra Señora de Sonsoles, Ávila

08003

Hospital del Mar, Barcelona

08036

Hospital Clinic i Provincial, Barcelona

08916

Hospital Germans Trias i Pujol, Barcelona

All Listed Sponsors
lead

Spanish Breast Cancer Research Group

OTHER

NCT01875367 - Phase III to Evaluate Patient´s Preference of Subcutaneous Trastuzumab vs Intravenous in HER2+ Advanced Breast Cancer | Biotech Hunter | Biotech Hunter