A Study of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Advanced and/or Metastatic Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

225

Participants

Timeline

Start Date

February 28, 2002

Primary Completion Date

March 31, 2006

Study Completion Date

January 31, 2008

Conditions
Breast Cancer
Interventions
DRUG

Xeloda

Participants will receive oral Xeloda, 950 mg/m\^2 twice a day on Days 1 to 14 of each 21-day cycle.

DRUG

Taxotere

Participants will receive Taxotere, 75 milligrams per meter-squared (mg/m\^2) in the Herceptin + Taxotere + Xeloda arm or 100 mg/m\^2 in the Herceptin + Taxotere arm, via IV infusion on Day 1 of each 21-day cycle. The lower starting dose will be used in the triple-therapy arm.

DRUG

Herceptin

Participants will receive Herceptin, 6 milligrams per kilogram (mg/kg) via IV infusion, on Day 1 of each 21-day cycle. The first dose will be a loading dose of 8 mg/kg in Cycle 1; the dose of 6 mg/kg will be given from Cycle 2 onward.

Trial Locations (51)

0

Panama City

2050

Camperdown

3002

Melbourne

3181

Melbourne

3220

Geelong

4066

Brisbane

4215

Southport

5011

Adelaide

6000

Perth

10103

San José

11526

Athens

13273

Marseille

14080

Distrito Federal

20089

Rozzano

20520

Turku

24047

Treviglio

25030

Besançon

25198

Lleida

26500

Pátrai

30033

Noale

35042

Rennes

37045

Legnago

38000

Grenoble

38100

Trento

50009

Zaragoza

64020

Monterrey

64060

Monterrey

65185

Karlstad

69310

Pierre-Bénite

71110

Heraklion

72189

Västerås

75231

Paris

97500

Mérida

91350-200

Porto Alegre

20560-120

Rio de Janeiro

01401-901

São Paulo

T2N 4N2

Calgary

K1H 8L6

Ottawa

G1S 4L8

Québec

01010

Guatemala City

80-214

Gdansk

71-730

Szczecin

08035

Barcelona

08208

Sabadell, Barcelona

IP4 5PD

Ipswich

LS9 7TF

Leeds

M20 4BX

Manchester

HA6 2RN

Northwood

OX3 7LJ

Oxford

SO16 6YD

Southampton

BS23 4TQ

Weston-super-Mare

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02748213 - A Study of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Advanced and/or Metastatic Breast Cancer | Biotech Hunter | Biotech Hunter