Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer

2014-08-27 03:14:07 | BioPortfolio


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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Breast Cancer


Temsirolimus plus Neratinib


Memorial Sloan-Kettering at Basking Ridge
Basking Ridge
New Jersey
United States




Memorial Sloan-Kettering Cancer Center

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:14:07-0400

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