HER-2 Positive Breast Cancer Clinical Trial
Official title:
A Phase II Study Evaluating The Efficacy And Tolerability Of Everolimus (RAD001) In Combination With Trastuzumab And Vinorelbine In The Treatment Of Progressive HER2-Positive Breast Cancer Brain Metastases
Purpose: This study is a single-arm, open-label phase II clinical trial testing the
hypothesis that daily everolimus plus weekly vinorelbine and trastuzumab will be effective,
safe, and tolerable among patients with human epidermal growth factor receptor 2
(HER2)-positive breast cancer brain metastases. Once enrolled, patients will receive
everolimus PO daily in combination with weekly intravenous (IV) vinorelbine and trastuzumab.
Cycles will be repeated every 3 weeks (21 days). At the time of progression, patients will
come off study.
Participants: Up to 35 adults over 21 with HER-2 positive breast cancer that has metastasized
to the brain.
STUDY OBJECTIVES Primary Objective -To determine the intracranial objective response rate of
mTOR inhibition (everolimus) in combination with vinorelbine and trastuzumab in the treatment
of HER2-positive, progressive breast cancer brain metastases as defined via modified RECIST
criteria.
Secondary Objectives
- To determine the intracranial objective response rate of mechanistic target of rapamycin
(mTOR) inhibition (everolimus) in combination with vinorelbine and trastuzumab in the
treatment of HER2-positive, progressive breast cancer brain metastases as defined by
MacDonald criteria.
- To evaluate the safety and tolerability of everolimus in combination with trastuzumab
and vinorelbine as assessed via the NCI CTCAE version 4.0
- To evaluate time to intracranial progression after administration of everolimus in
combination with trastuzumab and vinorelbine as defined via modified RECIST criteria
- To evaluate the extracranial objective response rate as determined by RECIST 1.1
criteria after administration of everolimus in combination with trastuzumab and
vinorelbine.
- To evaluate the extracranial time to progression as determined by RECIST 1.1 criteria
after administration of everolimus in combination with trastuzumab and vinorelbine.
- To evaluate progression free survival (PFS) and overall survival (OS) after
administration of everolimus in combination with trastuzumab and vinorelbine.
- To evaluate the impact of everolimus in combination with trastuzumab and vinorelbine on
quality of life as measured by the Functional Assessment of Cancer Therapy Breast
(FACT-B) and Functional Assessment of Cancer Therapy Brain (FACT-Br) questionnaires.
Exploratory Objective
-To evaluate biomarkers in archival tumor tissue samples and correlate with therapeutic
response to everolimus in combination with vinorelbine and trastuzumab.
Following Hepatitis B antiviral prophylaxis if required, or following screening and informed
consent if antiviral therapy is not needed, treatment will be initiated with everolimus PO
daily in combination with weekly intravenous (IV) vinorelbine and trastuzumab (Days 1, 8, and
15)
A cycle is defined as 3 weeks (21 days). Cycles of therapy will be repeated until documented
disease progression, unacceptable toxicity, or patient withdrawal from study for other
reasons, including death.
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