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RAD001 Plus Carboplatin in Breast Cancer Patients

2014-08-27 03:13:32 | BioPortfolio

Summary

This study will investigate the effectiveness of combination of carboplatin and investigational agent RAD001 in triple-negative breast cancer.

Description

This study is an open label phase II trial of carboplatin and RAD001 in women with triple-negative breast cancer. Carboplatin, at a dose of AUC 6, will be given as an IV infusion every three weeks. RAD001 will be given as a 5 mg pill daily with a run in of 3 patients. If there is a dose limiting toxicity (any toxicity requiring dose modification or interruption as per table 3.1) among the first 3 patients, that number will be increased to 6 patients. If the 5 mg dose is found to be tolerable among the first 3 patients, the RAD001 dose will be increased to a 10 mg pill daily. In the unexpected case of 2 or more DLT's at 5 mg/day or 1 or more DLT's in the additional 3 patients, further dosing will be reviewed by the PI in conjunction with the NYU DSMC. For any toxicity leading to treatment delays of >7 days, the carboplatin dose will be decreased to AUC of 5 in subsequent cycles, and with subsequent treatment delays >14 days the patient will be taken off the study regimen. Carboplatin will not be reduced for RAD001 related toxicities. Patients will be assessed for response every two cycles with either PET/CT or CT of the chest, abdomen, and pelvis and a bone scan. In addition patients will be followed with serial CEA and CA 27-29 levels. The patients will continue on the protocol until there is progression of disease or unacceptable toxicity.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Breast Cancer

Intervention

RAD001

Location

NYU Clinical Cancer Center
New York
New York
United States
10016

Status

Not yet recruiting

Source

New York University School of Medicine

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:32-0400

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