At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 49 enrolled
Drug / intervention
GW572016 +1 moredrug
Likely dose
Lapatinib 500 mg orallyAI-extracted
Key inclusion· 6
- ✓Locally advanced breast cancers (clinical/radiologic size ≥5 cm or surgically inoperable) or primary breast cancers with concomitant metastatic disease, Stage IIIb, IIIc, or IV
- ✓HER2 overexpressing tumors: HercepTest 3+, or ≥10% cells moderately/strongly HER2 positive, or semi-quantitative score ≥5, or gene amplified
- ✓WHO performance status <2 and life expectancy >6 months
- ✓Age >18 years
Key exclusion· 6
- ✕Brain or leptomeningeal disease
- ✕Cardiomyopathy or baseline LVEF <50%
- ✕Severe or uncontrolled hypertension, history of congestive heart failure, or severe coronary arterial disease
- ✕Malabsorption syndrome, disease significantly affecting gastrointestinal function, gastric/small bowel resection, or ulcerative colitis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Neoadjuvant Phase II Trial of GW572016 in HER2 Overexpressing Breast Cancer Patients: Biologic Correlative Study
In Brief
A Phase 2 clinical trial evaluating GW572016 and lapatinib for Breast Cancer. Completed, enrolled 49 participants across 3 sites.
Detailed Summary
We want to learn whether GW572016 is effective in breast cancers that have HER2.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsGlaxoSmithKline
Timeline
Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2004
First PostedSep 2005
Primary CompletionJun 2011
Study CompletionFeb 2012
TodayJul 2026
First PostedSep 21, 2005
Enrollment StartAug 1, 2004
Primary CompletionJun 1, 2011
Study CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 20.8 years ago
Interventions
GW572016drug
Lapatinib, 500 mg
lapatinibdrug
Lapatinib 500 mg PO