A Study Evaluating Trastuzumab Emtansine Plus Pertuzumab Compared With Chemotherapy Plus Trastuzumab and Pertuzumab for Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

444

Participants

Timeline

Start Date

June 25, 2014

Primary Completion Date

December 31, 2015

Study Completion Date

May 29, 2018

Conditions
Breast Neoplasms
Interventions
DRUG

Carboplatin

Carboplatin IV infusion at a dose to achieve an AUC of 6 mg\*min/mL q3w

DRUG

Docetaxel

Docetaxel 75 mg/m\^2 IV infusion q3w

DRUG

Pertuzumab

Pertuzumab 840 mg (loading dose); and 420 mg (maintenance dose) IV infusion q3w

DRUG

Trastuzumab

Trastuzumab 8 mg/kg (loading dose); and 6 mg/kg (maintenance dose) IV infusion q3w

DRUG

Trastuzumab Emtansine

Trastuzumab Emtansine 3.6 mg/kg IV infusion q3w

Trial Locations (79)

104

Mackay Memorial Hospital; Dept of Surgery, Taipei

112

Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology, Taipei

Taipei Veterans General Hospital, Taipei

807

Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery, Kaohsiung City

2610

Sint Augustinus Wilrijk, Wilrijk

2650

UZ Antwerpen, Edegem

3000

UZ Leuven Gasthuisberg, Leuven

4000

Clinique Saint-Joseph, Liège

5000

Clinique Ste-Elisabeth, Pharmacie, Namur

6351

Samsung Medical Center, Seoul

10041

National Taiwan Uni Hospital, Taipei

10408

National Cancer Center, Gyeonggi-do

10467

Montefiore Medical Center, The Bronx

11042

ProHEALTH Care Associates LLP, Lake Success

11490

Tri-Service General Hospital, Taipei

13009

Institut Paoli Calmettes, Marseille

13620

Seoul National University Bundang Hospital, Gyeonggi-do

15006

Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología, A Coruña

18009

Cherkassy Regional Oncological Hospital, Cherkassy

20014

IInstituto Oncologico de San Sebastian, Oncologikoa; Servicio de Oncologia, Donostia / San Sebastian

23007

Complejo Hospitalario de Jaen, Jaén

25030

HOPITAL JEAN MINJOZ; Oncologie, Besançon

25198

Hospital Universitari de Lleida Arnau de Vilanova, Lleida

28007

Hospital General Universitario Gregorio Marañon; Servicio de Oncologia, Madrid

28040

Hospital Universitario Clínico San Carlos; Servicio de Oncologia, Madrid

28050

Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica, Madrid

28204

Levine Cancer Institute, Charlotte

28223

Hospital Quiron de Madrid; Servicio de Oncologia, Madrid

28806

Hope A Women's Cancer Center, Asheville

29010

Hospital Universitario Virgen de la Victoria, Málaga

29200

Hopital Morvan, Brest

29414

Roper Bon Secours St. Francis Cancer Center, Charleston

32806

Md Anderson Cancer Center Orlando, Orlando

33021

Memorial Cancer Institute, Hollywood

37203

Sarah Cannon Research Institute, Nashville

40235

Luisenkrankenhaus GmbH, Brustzentrum, Düsseldorf

41013

Hospital Universitario Virgen del Rocio, Seville

43102

State Medical Academy; Oncology, Dnipropetrovsk

44202

Centre Catherine De Sienne, Nantes

44805

Centre Rene Gauducheau, Saint-Herblain

46010

Hospital Clinico Universitario de Valencia, Valencia

49000

Ico - Paul Papin, Angers

50009

Hospital Universitario Miguel Servet; Servicio Oncologia, Zaragoza

55131

Universitätsklinikum Mainz, Mainz

59020

Centre Oscar Lambret, Lille

61070

Karkiv Regional Oncology Center, Kharkiv

67091

Nouvel Hopital Civil - CHU Strasbourg, Strasbourg

71032

Klinikum Sindelfingen-Böblingen; Frauenklinik, Böblingen

77030

MD Anderson Cancer Center, Houston

79031

Lvov State Regional Center, Lviv

80336

Interdisziplinäres Onkologisches Zentrum, München

85925

CHD Les Oudairies, La Roche-sur-Yon

89052

Comprehensive Cancer Centers of Nevada - Henderson, Henderson

90404

UCLA Hematology/Oncology, Santa Monica

91054

Universitätsklinikum Erlangen; Frauenklinik, Erlangen

92835

St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr, Fullerton

93401

Coastal Integrative Cancer Care, San Luis Obispo

93454

Central Coast Medical Oncology, Santa Maria

115478

S.I. Russian Oncological Research Center n.a. N.N. Blokhin, Moscow

143423

Moscow City Oncology Hospital #62, Moscovskaya Oblast

197022

Saint-Petersburg City Clinical Oncology Dispensary, Saint Petersburg

305524

Regional Oncology Hospital Of Kursk; Chemotherapy, Kislino, Kursk Region

410004

"Railway Clinical Hospital on Saratov - 2 Station Oao Rzhd", Saratov

460021

State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis, Orenburg

90095-1772

Cancer Care Assoc Med Group, Los Angeles

04074

New England Cancer Specialists, Scarborough

T6G 1Z2

Cross Cancer Institute ; Dept of Medical Oncology, Edmonton

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

M5B 1W8

St. Michael'S Hospital, Toronto

H2L 4M1

Chum Hospital Notre Dame, Montreal

H3T 1E2

McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology, Montreal

G1S 4L8

CHU de Québec - Hôpital du Saint-Sacrement / ONCOLOGY, Québec

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Seoul

05505

Asan Medical Center - Oncology, Seoul

08208

Corporacio Sanitaria Parc Tauli; Servicio de Oncologia, Sabadell

05071

Hospital Nuestra Señora de Sonsoles; servicio de Oncologia, Ávila

08003

Hospital del Mar; Servicio de Oncologia, Barcelona

08006

Fundacio Santa Creu I Sant Pau, Barcelona

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02131064 - A Study Evaluating Trastuzumab Emtansine Plus Pertuzumab Compared With Chemotherapy Plus Trastuzumab and Pertuzumab for Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer | Biotech Hunter | Biotech Hunter