A Study of Lapatinib in Combination With Everolimus in Patients With Advanced, Triple Negative Breast Cancer
Part of paid clinical trials in Atlanta, Georgia.
- Sponsor
- Emory University
- Study ID
- NCT01272141
- Phase
- PHASE2
- Status
- Terminated
Conditions
- Breast Cancer
- Breast Neoplasms
- Cancer of the Breast
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Lapatinib and Everolimus — DRUGLapatinib: 1250 mg by mouth daily Everolimus: 5mg by mouth daily
Study Details
The patient is being asked to join this clinical research study to find out if lapatinib, an agent that targets a protein, called epidermal growth factor receptor (EGFR) on the surface of cancer cells in combination with everolimus, an agent that targets a protein in the cancer cell, called mammalian target of rapamycin (mTOR) is effective in metastatic triple negative breast cancers that are no longer controlled by standard chemotherapy.
Key Dates
- Start date
- Dec 31, 2010
- Status verified
- Sep 2014
- Primary completion
- Jan 31, 2013
- Completion
- Jan 31, 2014
Study Design
- Enrollment
- 5 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm A: Lapatinib plus Everolimus
Primary Outcome Measure
Overall Response Rate Will Measured Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Tumor Assessment for All Lesions Must be Performed Every Eight Weeks While on Study by CT Scan. [ Time Frame: Tumor assessment for all lesions must be performed by CT scan every 8 weeks while on study. ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Emory Midtown (Crawford Long Hospital) | Atlanta | Georgia | 30308 | - |
| Emory University Winship Cancer Institute | Atlanta | Georgia | 30329 | - |
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | - |
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