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The purpose of this study is to test the safety and benefit of two new drugs for the treatment of breast cancer. The patient is eligible for the study because their breast cancer has grown in spite of standard treatment. The two drugs tested in the study, Neratinib and Temsirolimus, will be given together. Also, this study will help the investigators learn why therapy directed against HER2 sometimes stops working.
Phase I Design
A standard, 3+3, dose escalation schedule will be used. Between 6 and 12 patients will likely be necessary to determine the MTD of temsirolimus in combination with neratinib. There will be no intrapatient dose escalation. The starting dose of temsirolimus is 8 mg administered intravenously weekly (dose level 1). Three patients will initially be enrolled in each cohort.
Phase II Design
The phase II portion of this trial will be comprised of two cohorts—HER2-amplified and triple negative breast cancer—each of which has a Simon two-stage design to determine the efficacy of temsirolimus when administered in combination with neratinib. Both pathologic subtypes of patients will be studied separately though accrual will be simultaneous. Response (RECIST criteria) will be assessed every 8 weeks (every 2 cycles) after the start of therapy.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Temsirolimus plus Neratinib
Memorial Sloan-Kettering at Basking Ridge
Memorial Sloan-Kettering Cancer Center
Published on BioPortfolio: 2014-08-27T03:14:07-0400
This is a Phase 2, therapeutic-exploratory, adaptive design, open-label, multicenter, multinational study evaluating neratinib monotherapy and neratinib plus temsirolimus combination thera...
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