Conditions: Metastatic Breast Cancer With Intracranial Metastases
Keywords: HER2-positive breast cancer intracranial metastases lapatinib cabazitaxel
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 11
Healthy volunteers: no

Brief summary:
This phase II trial will combine two agents, cabazitaxel and lapatinib, to treat patients with metastatic breast cancer (MBC) which has metastasized to the brain. The first portion of the study will determine the optimal dose of the cabazitaxel/lapatinib combination to administer to patients. After determining the optimal dose, patients will continue treatment with cabazitaxel and lapatinib to assess response to treatment with these agents.

Detailed description:
This is an open-label, non-randomized, Phase II study with a lead-in safety cohort. Through the safety lead-in portion of this trial we will define the optimal dose of cabazitaxel when given in combination with lapatinib for patients with HER2-positive MBC and CNS metastases. The Phase II portion will further assess intracranial response rate in patients with HER2-positive MBC and CNS metastases. Toxicity and progression free survival (PFS) will be obtained and evaluated. The trial will be conducted at multiple study sites by SCRI Development Innovations.

Arms:
arm 1: * Cabazitaxel 1-hour IV infusion on Day 1 of each 3 week cycle (dose to be determined)
* Lapatinib PO once daily (dose to be determined)

Treatment cycles will be repeated every 3 weeks.

Interventions: intervention 1: cabazitaxel intervention 2: lapatinib
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: