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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lapatinib and Everolimus — DRUG
    Lapatinib: 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)

FacilityCityStateZIPSite coordinators
Emory Midtown (Crawford Long Hospital)AtlantaGeorgia30308-
Emory University Winship Cancer InstituteAtlantaGeorgia30329-
Grady Memorial HospitalAtlantaGeorgia30303-

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