NCT00524303 - Lapatinib +/- Trastuzumab In Addition To Standard Neoadjuvant Breast Cancer Therapy. | Biotech Hunter

Enrollment

100

Participants

Timeline

Start Date

August 31, 2007

Primary Completion Date

October 31, 2010

Study Completion Date

August 31, 2015

Conditions

Neoplasms, Breast

Interventions

DRUG

Trastuzumab

4mg/kg IV loading dose followed by 2mg/kg IV weekly

DRUG

Paclitaxel

80mg/m2 IV weekly for 4 (21 day) cycles

DRUG

FEC75

5FU 500mg/m2 + Epirubicin 75 mg/m2 + cyclophosphamide 500 mg/m2 IV on day 1 of 4 (21 day) cycles

DRUG

Lapatinib

1250 mg oral daily dose in arm 2, 750 mg oral daily dose for FEC cycles and then 1000 mg oral daily dose during the Paclitaxel cycles in arm 3

Trial Locations (23)

19107

GSK Investigational Site, Philadelphia

23502

GSK Investigational Site, Norfolk

33028

GSK Investigational Site, Pembroke Pines

33176

GSK Investigational Site, Miami

34667

GSK Investigational Site, Hudson

46219

GSK Investigational Site, Indianapolis

75067

GSK Investigational Site, Lewisville

75231

GSK Investigational Site, Dallas

75246

GSK Investigational Site, Dallas

75702

GSK Investigational Site, Tyler

76022

GSK Investigational Site, Bedford

77024

GSK Investigational Site, Houston

77479

GSK Investigational Site, Sugar Land

78731

GSK Investigational Site, Austin

79915

GSK Investigational Site, El Paso

80220

GSK Investigational Site, Denver

89052

GSK Investigational Site, Henderson

90057

GSK Investigational Site, Los Angeles

92708

GSK Investigational Site, Fountain Valley

98117

GSK Investigational Site, Seattle

98902

GSK Investigational Site, Yakima

77702-1449

GSK Investigational Site, Beaumont

75320-2510

GSK Investigational Site, Dallas