Trastuzumab and RAD001 in Patients With Human Epidermal Growth Receptor 2 (HER-2) Overexpressing Breast Cancer
Status:
Completed
Trial end date:
2013-02-01
Target enrollment:
Participant gender:
Summary
Primary Objectives:
1. To identify the optimal dose and pharmacokinetics of RAD001 in combination with
trastuzumab in a Phase I trial
2. To determine the efficacy of RAD001 plus trastuzumab in HER-2-overexpressing patients
with resistance to trastuzumab-based therapy for metastatic breast cancer in a Phase II
trial.
1. Trastuzumab resistance will be defined as the development of progressive disease
after trastuzumab-based therapy for metastatic breast cancer. Patients who develop
metastases while receiving adjuvant or neoadjuvant trastuzumab will be eligible.
2. Efficacy would be measured by the rate of objective response plus stable disease
lasting 6 months (complete response (CR) + partial response (PR) + stable disease
SD).
Secondary objectives:
1. To determine the pharmacokinetics of RAD001 in combination with trastuzumab. In the
phase II portion of the study, pharmacokinetic studies will be optional.
2. To determine the nature and degree of toxicity of RAD001 in combination with trastuzumab
in this cohort of patients
3. To determine expression levels of total and phosphorylated mTOR and p70S6K-T389-P as
well as relevant downstream signaling components (e.g., S6, 4E-BP1) in pre- and post-
treatment tumor samples.
4. To correlate biomarker expression with response to therapy.