At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 242 enrolled
Drug / intervention
lapatinibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of Lapatinib for Brain Metastases in Subjects With ErbB2-Positive Breast Cancer Following Trastuzumab-based Systemic Therapy and Cranial Radiotherapy
In Brief
A Phase 2 clinical trial evaluating lapatinib for Neoplasms, Breast. Completed, enrolled 242 participants across 74 sites in 17 countries.
Detailed Summary
Determine how safe and effective lapatinib is when used to treat patients with ErbB2 overexpressing breast cancer that has spread to the brain and is still progressing there even after radiation treatment using WBRT (whole brain radiotherapy) or SRS (stereotactic radiosurgery) to the brain. Lapatinib is an oral drug that will be taken every day. Tests for safety and efficacy will be performed every 4 weeks or 8 weeks (depending on the test) during the course of the study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms, Breast
CountriesAustralia, Austria, Belgium, Canada, France, Germany, Greece, India, Italy, Japan, Poland, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2005
First PostedDec 2005
Primary CompletionSep 2007
Study CompletionMar 2018
TodayJul 2026
First PostedDec 9, 2005
Enrollment StartDec 2, 2005
Primary CompletionSep 25, 2007
Study CompletionMar 15, 2018
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 20.6 years ago
Interventions
lapatinibdrug
tyrosine kinase inhibitor