Conditions: Neoplasms, Breast
Keywords: brain metastases ErbB2 lapatinib Breast Cancer HYCAMTIN topotecan capecitabine metastatic breast cancer TYKERB XELODA
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 22
Healthy volunteers: no

Brief summary:
This study is for 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. The study will determine how safe and effective lapatinib is when given in combination with capecitabine to treat patients with ErbB2 overexpressing breast cancer that has spread to the brain. Lapatinib is an oral drug that will be taken every day. Tests for safety and efficacy will be performed regularly during the course of the study.

Detailed description:

Arms:
arm 1: A total of 55 isubjects will be enrolled into this arm. Subjects with progression of CNS and/or non-CNS disease will be considered progressors. At the time of radiographically-documented CNS and/or non-CNS disease progression, a subject randomized to this arm will be allowed to cross over to the alternative arm. arm 2: A total of 55 isubjects will be enrolled into this arm. Subjects with progression of CNS and/or non-CNS disease will be considered progressors. At the time of radiographically-documented CNS and/or non-CNS disease progression, a subject randomized to this arm will be allowed to cross over to the alternative arm.

Interventions: intervention 1: capecitabine intervention 2: topotecan intervention 3: lapatinib
Intervention descriptions: intervention 1: capecitabine 2000mg/m2/day orally, Days 1-14, every 21 days intervention 2: topotecan intravenous (IV, in the vien) 3.2mg/m2 Days 1, 8 and 15; every 28 days intervention 3: lapatinib administered 1250mg once daily orally

Protocol document: