A Phase II, Randomized, Open-label Study of Lapatinib Plus Chemotherapy Versus Trastuzumab Plus Chemotherapy in HER2-positive and p95HER2-positive Metastatic Breast Cancer



Status:Archived
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:February 2011
End Date:March 2018

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A Phase II, Randomized, Open-label Study of Lapatinib Plus Chemotherapy Versus Trastuzumab Plus Chemotherapy as First-line Treatment for Women With HER2-positive and p95HER2-positive Metastatic Breast Cancer


This is a Phase II, randomized, open-label, multi-center study evaluating the efficacy and
safety of lapatinib in combination with chemotherapy versus trastuzumab in combination with
chemotherapy in women with HER2-positive and p95HER2-positive metastatic breast cancer
(MBC). Eligible subjects will have newly diagnosed metastatic breast cancer (Stage IV)
either as a primary diagnosis or as a recurrence following treatment of curative intent; not
have received systemic or local treatment for MBC and have breast cancer that is positive
for HER2 and p95HER2. The primary objective is to compare progression-free survival (PFS)
of lapatinib plus chemotherapy versus trastuzumab plus chemotherapy as first-line treatment
in subjects with MBC exhibiting concurrent HER2 overexpression (and/or gene amplification)
and expression of carboxy-terminal fragments of HER2 (p95HER2). The secondary objectives are
to evaluate overall survival, overall response rate, clinical benefit response rate and the
safety as well as tolerability of lapatinib plus chemotherapy and trastuzumab plus
chemotherapy.



We found this trial at
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Glendale, Arizona 85304
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Philadelphia, PA
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Ames, Iowa 50010
McFarland Clinic, PC It has been over 65 years since the founders of McFarland Clinic...
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Anaheim, California 92807
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Aurora, Colorado 80010
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Austin, Texas 78705
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Cherry Hill, New Jersey 08003
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Exeter, New Hampshire 03833
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Fargo, North Dakota 58122
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Knoxville, Tennessee 37916
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La Crosse, Wisconsin 54601
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La Crosse, WI
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1 Medical Center Drive
Morgantown, West Virginia 26506
304-598-4800
West Virginia University Hospitals Inc. WVU Healthcare is two corporations, University Health Associates and WVU...
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Morgantown, WV
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New Haven, Connecticut 06520
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Roswell, Georgia 30076
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Roswell, GA
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Washington, Washington DC 20007
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Washington, DC
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