Phase I/II Study of Weekly Abraxane and RAD001 in Women with Locally Advanced or Metastatic Breast Cancer. A Study of the Cancer Institute of New Jersey Oncology Group

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Phase I/II Study of Weekly Abraxane and RAD001 in Women with Locally Advanced or Metastatic Breast Cancer. A Study of the Cancer Institute of New Jersey Oncology Group

The purpose of this study is to determine what dose of RAD001and Abraxane is safe to use when the two drugs are used at the same time. Other goals in this study are to learn about the effect of RAD001 and Abraxane on tumor growth; to find out what amount of RAD001 is present in the blood when it is combined with Abraxane; and to learn more about certain genes that produce proteins that may help predict or show an effect (a response to treatment) of this drug combination. Phase I: To determine the maximum tolerated dose (MTD) of RAD001 in combination of weekly Abraxane and determine the Phase II dose of RAD001.Phase II: To determine the activity on tumors, of the combination of RAD001 and Abraxane at the Phase II dose in patients with advanced breast cancer.

Protocol Number040803
Principal InvestigatorDeborah Toppmeyer
PhasePhase I/II
ScopeLocal
Applicable Disease SitesBreast - Female
Therapies InvolvedChemotherapy multiple agents systemic
Participating InstitutionsCooper Hospital/University Medical Center
Robert Wood Johnson University Hospital at Hamilton
The Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.