A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Women With Locally Advanced Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

330

Participants

Timeline

Start Date

May 31, 2002

Primary Completion Date

July 31, 2012

Study Completion Date

July 31, 2012

Conditions
Breast Cancer
Interventions
DRUG

Trastuzumab

8mg/kg IV on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycle 2 up a maximum of Cycle 17

DRUG

Doxorubicin

60 mg/m2 IV on Day 1 of Cycles 1 through 3

DRUG

Paclitaxel

150 mg/m2 IV on Day 1 of Cycles 1 through 3, followed by 175 mg/m2 IV on Day 1 of Cycles 4 through 7

DRUG

CMF

CMF: Cyclophosphamide (600 mg/m2 IV bolus), methotrexate (40 mg/m2 IV bolus), 5-fluorouracil (600 mg/m2 IV bolus) on Day 1 of Cycles 8 through 10

Trial Locations (36)

1090

Vienna

11407

Jerez de la Frontera

20080

Donostia / San Sebastian

20133

Milan

21100

Varese

27100

Pavia

28041

Madrid

30035

Mirano

31033

Castelfranco Veneto

32100

Bellunoi

33100

Udine

36014

Santorso

36100

Vicenza

38100

Trento

40138

Bologna

41012

Carpi

46009

Valencia

46010

Valencia

50009

Zaragoza

56100

Pisa

71013

San Giovanni Rotondo

80637

München

107005

Moscow

115478

Moscow

117837

Moscow

129128

Moscow

197022

Saint Petersburg

197758

Saint Petersburg

420029

Kazan'

07100

Sassari

1099-023

Lisbon

08022

Barcelona

08035

Barcelona

08041

Barcelona

08907

Barcelona

08221

Terrassa

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT01998906 - A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Women With Locally Advanced Breast Cancer | Biotech Hunter | Biotech Hunter