Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer
Part of paid clinical trials in San Francisco, California.
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT00263588
- Phase
- PHASE2
- Status
- Completed
Conditions
- Neoplasms, Breast
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- lapatinib — DRUGtyrosine kinase inhibitor
Study Details
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.
Key Dates
- Start date
- Dec 2, 2005
- Status verified
- Nov 2019
- Primary completion
- Sep 25, 2007
- Completion
- Mar 15, 2018
Study Design
- Enrollment
- 242 participants (actual)
- Allocation
- NON_RANDOMIZED
- Primary purpose
- TREATMENT
Arms
- Experimental: single arm750 mg lapatinib administered orally twice daily
Primary Outcome Measure
The Number of Participants With Central Nervous System (CNS) Best Overall Response [ Time Frame: time from baseline to data cutoff (25 Sept 2007); approximately 2 years ]