Cabazitaxel Plus Lapatinib as Therapy for HER2-Positive Metastatic Breast Cancer Patients With Intracranial Metastases
Part of paid clinical trials in Fort Myers, Florida.
- Sponsor
- SCRI Development Innovations, LLC
- Study ID
- NCT01934894
- Phase
- PHASE2
- Status
- Terminated
Conditions
- Metastatic Breast Cancer With Intracranial Metastases
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- cabazitaxel — DRUG
- lapatinib — DRUG
Study Details
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.
Key Dates
- Start date
- May 31, 2014
- Status verified
- Jun 2017
- Primary completion
- Feb 29, 2016
- Completion
- Apr 30, 2017
Study Design
- Enrollment
- 11 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: cabazitaxel and lapatinib combination* 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.
Primary Outcome Measure
CNS Objective Response [ Time Frame: every 6 weeks thru cycle 8, then every 9 weeks until treatment discontinuation, projected 1 year ]
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Florida Cancer Specialists - South | Fort Myers | Florida | 33916 | - |
| Florida Cancer Specialists-North | St. Petersburg | Florida | 33705 | - |
| Oncology Hematology Care Inc. | Cincinnati | Ohio | 45242 | - |
| Tennessee Oncology | Nashville | Tennessee | 37203 | - |