Trials / Completed
CompletedNCT00263588
Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer
A Phase II Study of Lapatinib for Brain Metastases in Subjects With ErbB2-Positive Breast Cancer Following Trastuzumab-based Systemic Therapy and Cranial Radiotherapy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 242 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | lapatinib | tyrosine kinase inhibitor |
Timeline
- Start date
- 2005-12-02
- Primary completion
- 2007-09-25
- Completion
- 2018-03-15
- First posted
- 2005-12-09
- Last updated
- 2019-12-12
- Results posted
- 2019-12-12
Locations
74 sites across 17 countries: United States, Australia, Austria, Belgium, Canada, France, Germany, Greece, India, Italy, Japan, Poland, Spain, Sweden, Switzerland, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT00263588. Inclusion in this directory is not an endorsement.