Breast Cancer Clinical Trial
Official title:
A Phase I/II Trial of Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer
This is an open-label, single arm, multi-center, multi-national, adaptive design, dose-escalation Phase 1/2 study to determine the maximum tolerated dose (MTD) of temsirolimus with daily neratinib, and to determine the safety and efficacy of this combination when given to patients with advanced breast carcinoma, specifically trastuzumab-refractory HER2-amplified disease or triple-negative disease.
Phase I Design A standard, 3+3, dose escalation schedule to determine the MTD of temsirolimus
in combination with neratinib with no intrapatient dose escalation and a starting dose of
temsirolimus 8 mg administered intravenously (IV) weekly (dose level 1) and three patients
enrolled in each cohort.
Phase II Design The phase II portion of this trial is comprised of three cohorts. Two of the
cohorts utilized a Simon two-stage design to determine the sample size to assess the efficacy
of temsirolimus when administered in combination with neratinib: HER2-amplified and triple
negative breast cancer. The third cohort was a single stage design with HER2-amplified
patients and dose escalation.
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