Participant Preference of Subcutaneous (SC) Versus Intravenous (IV) Herceptin (Trastuzumab) in Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

488

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

May 31, 2013

Study Completion Date

December 31, 2015

Conditions
Breast Neoplasms
Interventions
DRUG

Herceptin

Herceptin will be given on Day 1 of each 3-week cycle for a total of 18 cycles. If study treatment for Cycle 1 is IV Herceptin, the initial dose will be a loading dose of 8 milligrams per kilogram (mg/kg) for de novo participants who start Herceptin treatment in the study. For all other cycles where IV Herceptin is given and for non-de novo participants, the dose will be 6 mg/kg. The SC dose will be 600 milligrams (mg) for both the SID and vial formulations for all cycles where SC Herceptin is given.

DRUG

Herceptin

Herceptin will be given on Day 1 of each 3-week cycle for a total of 18 cycles. If study treatment for Cycle 1 is IV Herceptin, the initial dose will be a loading dose of 8 mg/kg for de novo participants who start Herceptin treatment in the study. For all other cycles where IV Herceptin is given and for non-de novo participants, the dose will be 6 mg/kg. The SC dose will be 600 mg for both the SID and vial formulations for all cycles where SC Herceptin is given.

DEVICE

Single-Use Injection Device

The SID will be used, containing Herceptin 600 mg per 5 milliliters (mL).

DEVICE

Single-Use Injection Device

The SID will be used, containing Herceptin 600 mg per 5 mL.

Trial Locations (75)

5000

Odense

5405

Baden

7100

Vejle

7400

Herning

8008

Zurich

10713

Berlin

14004

Córdoba

14076

Caen

15517

Fürstenwalde

16132

Genoa

19002

Guadalajara

20132

Milan

20141

Milan

20246

Hamburg

22004

Huesca

25030

Besançon

27100

Pavia

27310

Gaziantep

28046

Madrid

28905

Madrid

29010

Málaga

30625

Hanover

33006

Oviedo

33076

Bordeaux

35042

Rennes

35100

Bornova, ?zm?r

38700

La Tronche

39104

Magedburg

41009

Seville

41014

Seville

45136

Essen

45657

Recklinghausen

48903

Barakaldo

49021

Zamora

50011

Antella (FI)

55131

Mainz

55185

Jönköping

63188

Eskilstuna

67065

Strasbourg

69373

Lyon

72000

LeMans

75970

Paris

80187

Gävle

85186

Sundsvall

89073

Ulm

92210

Saint-Cloud

93009

Bobigny

94469

Deggendorf

98617

Meiningen

115478

Moscow

197758

Saint Petersburg

420029

Kazan'

460021

Orenburg

620905

Yekaterinburg

664035

Irkutsk

L4M 6M2

Barrie

L6R 3J7

Brampton

N2G 1G3

Kitchener

P6A 2C4

Sault Ste. Marie

M4N 3M5

Toronto

S7N 4H4

Saskatoon

05100

Terni

80-952

Gdansk

02-781

Warsaw

Unknown

Saint Petersburg

08024

Barcelona

01120

Adana

06018

Ankara

BN2 5BE

Brighton

CF14 2TL

Cardiff

CM1 7ET

Chelmsford

ME16 9QQ

Maidstone

NG5 1PB

Nottingham

PE3 6DA

Peterborough

TR1 3LJ

Truro

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT01401166 - Participant Preference of Subcutaneous (SC) Versus Intravenous (IV) Herceptin (Trastuzumab) in Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer | Biotech Hunter | Biotech Hunter