A Study Evaluating Pertuzumab (Perjeta) Combined With Trastuzumab (Herceptin) and Standard Anthracycline-based Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced, Inflammatory, or Early-stage Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

401

Participants

Timeline

Start Date

July 14, 2014

Primary Completion Date

March 3, 2016

Study Completion Date

August 25, 2020

Conditions
Breast Cancer
Interventions
DRUG

5-Fluorouracil

Participants will receive 5-fluorouracil 500 mg/m\^2 IV on Day 1 of each cycle q3w.

DRUG

Cyclophosphamide

Participants will receive cyclophosphamide 600 milligrams per square meter (mg/m\^2) intravenous (IV) given on Day 1 of each cycle q2w.

DRUG

Docetaxel

Participants will receive docetaxel at a starting dose of 75 mg/m\^2 IV for the first cycle and the dose may be escalated to 100 mg/m\^2 for subsequent cycles q3w.

DRUG

Doxorubicin

Participants will receive doxorubicin 60 mg/m\^2 IV on Day 1 of each cycle q2w.

DRUG

Epirubicin

Participants will receive epirubicin 100 mg/m\^2 IV on Day 1 of each cycle q3w.

DRUG

Paclitaxel

Participants will receive paclitaxel 80 mg/m\^2 IV given weekly.

DRUG

Pertuzumab

Participants will receive pertuzumab at a loading dose of 840 milligrams (mg) IV loading dose, then 420 mg IV q3w.

DRUG

Trastuzumab

Participants will receive trastuzumab at a loading dose of 8 milligrams per kilogram (mg/kg) IV, then 6 mg/kg IV q3w.

Trial Locations (80)

2100

Rigshospitalet; Onkologisk Klinik, København Ø

2730

Herlev Hospital; Afdeling for Kræftbehandling, Herlev

5021

Haukeland Universitetssjukehus; Klinisk forskningspost, Bergen

7100

Vejle Sygehus; Onkologisk Afdeling, Vejle

10011

Mount Sinai Beth Israel Comprehensive Cancer Center, New York

10065

Memorial Sloan Kettering Cancer Center, New York

10126

A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica, Turin

10604

MSKCC @ West Harrison, Harrison

11570

MSKC @ Rockville, Rockville Centre

11725

MSKCC @ Commack, Commack

14004

Hospital Universitario Reina Sofia; Servicio de Oncologia, Córdoba

15009

Centro Oncológico Gallego José Antonio Quiroga y Piñeiro, Servicio de Oncologia, A Coruña

16816

Ruppiner Kliniken, Klinik fuer Gynaekologie und Geburtshilfe, Neuruppin

20007

MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center), Washington D.C.

20010

Washington Cancer Institute at MedStar Washington Hospital Center., Washington D.C.

24014

Blue Ridge Cancer Care, Roanoke

28006

Hospital Universitario de la Princesa; Servicio de Oncologia, Madrid

28034

Hospital Ramon y Cajal; Servicio de Oncologia, Madrid

30060

Northwest Georgia Oncology Centers PC - Marietta, Marietta

32256

Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy), Jacksonville

34070

Clinique Clementville; Hopital De Jour, Montpellier

35042

Centre Eugene Marquis; Unite Huguenin, Rennes

36604

University of South Alabama; Mitchell Cancer Institute, Mobile

37073

Dres.Andreas Ammon und Dirk Meyer, Göttingen

41009

Hospital Universitario Virgen Macarena; Servicio de Oncologia, Seville

45004

Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia, Toledo

50012

Ospedale Santa Maria Annunziata; Oncologia, Bagno a Ripoli

54100

Centre D'Oncologie de Gentilly; Oncology, Nancy

55407

Allina Health, Virginia Piper Cancer Institute, Minneapolis

58100

Ospedale Della Misericordia; U.O. Di Medicina Ia - Oncologia Medica, Grosseto

59020

Centre Oscar Lambret; Cancerologie Gynecologique, Lille

63225

Dres. Andreas Köhler und Roswitha Fuchs, Langen

64111

Saint Lukes Hospital Cancer Institute, Kansas City

64710

Centro de Diagnóstico y Tratamiento Integral de Mama, Hospital San José Tec de Monterrey, Monterrey

69373

Centre Leon Berard; Departement Oncologie Medicale, Lyon

72015

Clinique Victor Hugo; Chimiotherapie, Le Mans

73100

"Asl Le-Ospedale Vito Fazzi;U.O. Oncologia", Lecce

73120

Mercy Clinic Oklahoma Communties, Inc, Oklahoma City

75231

Institut Curie; Oncologie Medicale, Paris

79106

Harrington Cancer Center, Amarillo

81675

Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde, München

84112

University of Utah; Huntsman Cancer Hospital, Salt Lake City

87401

San Juan Oncology Associates, Farmington

90146

Casa Di Cura Di Alta Specialita La Maddalena; Dept. Oncologico Di Iii Livello, Palermo

94115

California Pacific Medical Center, San Francisco

94805

Institut Gustave Roussy; Departement Oncologie Medicale, Villejuif

94904

Marin Specialty Care, Greenbrae

98225

PeaceHealth St. Joseph Cancer Center, Bellingham

98405

Northwest Medical Specialties, Tacoma

01201

Berkshire Medical Center, Pittsfield

07601

Hackensack University Medical Center, Hackensack

07962

Regional Cancer Care Associates LLC - Morristown, Morristown

E1C 6Z8

Horizon Health Network, Moncton

L4M 6M2

Royal Victoria Hospital, Barrie

H7M 3L9

Cite de La Sante de Laval; Hemato-Oncologie, Laval

H3T1M5

St Mary's Hospital Center, Montreal

H4J 1C5

Hopital Sacre-Coeur Research Centre, Montreal

S4T 7T1

Allan Blair Cancer Centre, Regina

06189

Centre Antoine Lacassagne; Hopital De Jour A2, Nice

01307

"Universitätsklinikum Carl Gustav Carus; Frauenheilkunde und Geburtshilfe", Dresden

00161

Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche, Rome

04980

Iem-Fucam, D.F.

0450

Oslo universitetssykehus HF, Ullevål, Kreftsenteret, Oslo

15-027

Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej, Bialystok

30-688

Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii, Krakow

05-400

Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii, Otwock

61-866

Wielkopolskie Centrum Onkologii; im. Marii Skłodowskiej-Curie, Poznan

1400-038

Centro Clinico Champalimaud; Oncologia Medica, Lisbon

1649-035

Hospital de Santa Maria; Servico de Oncologia Medica, Lisbon

2674-514

Hospital Beatriz Angelo; Departamento de Oncologia, Loures

4200-072

IPO do Porto; Servico de Oncologia Medica, Porto

08916

Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia, Badalona

BA1 3NG

Royal United Hospital; Oncology Department, Bath

BH7 7DW

Royal Bournemouth Hospital; Oncology, Bournemouth

SE1 9RT

Guys & St Thomas Hospital; Department of Oncology, London

SW3 6JJ

Royal Marsden Hospital - Fulham; Oncology Department, London

NE7 7DN

Freeman Hospital; Northern Centre For Cancer Care, New Castle Upon Tyne

OX3 7LJ

Churchill Hospital; Oxford Cancer and Haematology Centre, Oxford

PE3 9GZ

Peterborough City Hospital, Edith Cavell Campus; Oncology Department, Peterborough

SM2 5PT

Royal Marsden Hospital; Dept of Medical Oncology, Sutton

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02132949 - A Study Evaluating Pertuzumab (Perjeta) Combined With Trastuzumab (Herceptin) and Standard Anthracycline-based Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced, Inflammatory, or Early-stage Breast Cancer | Biotech Hunter | Biotech Hunter