A Phase II Study of Lapatinib for Brain Metastases in Subjects With ErbB2-Positive Breast Cancer Following Trastuzumab-based Systemic Therapy and Cranial Radiotherapy

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.

本研究旨在明确拉帕替尼（lapatinib）用于治疗ErbB2过表达型乳腺癌脑转移患者的安全性与有效性，此类患者经全脑放疗（whole brain radiotherapy, WBRT）或立体定向放射外科（stereotactic radiosurgery, SRS）治疗后，颅内病灶仍呈进展状态。拉帕替尼为每日口服给药的药物。研究期间将每4周或每8周（依检测项目类别而定）开展安全性与有效性评估。