Randomized Phase II Trial of Trastuzumab or EVEROLIMUS in Hormone-refractory Metastatic Breast Cancer
The purpose of this study is to investigate if trastuzumab or everolimus alone or in
combination are effective for metastatic breast cancers that are no longer controlled with (
are resistant to) hormonal therapies, and express small to moderate amounts of HER2/neu.
There is no standard of care for disease once it becomes resistant to hormonal therapy, and
many patients are treated with chemotherapy. Trastuzumab alone or trastuzumab in
combination with everolimus, have not been previously used to treat breast cancers than are
resistant to hormonal therapies and have small to moderate amounts of HER2/neu. Everolimus
alone has been demonstrated to improve outcome for patients with hormone-resistant
metastatic breast cancer that is resident to hormonal agents.
In this study participants will be randomized 50:50 to receive trastuzumab alone or
everolimus alone alone with the most recent hormonal agent they have taken. At the time of
disease progression, patients randomized to receive trastuzumab will start everolimus, and
patients randomized to everolimus will receive trastuzumab, so that all patients ultimately
receive both agents. Trastuzumab is widely used to treat all stages of breast cancer, and is
currently approved for the treatment of early and advanced breast cancer that have very high
amounts of HER2/neu. Everolimus, when given with hormonal therapy, has been demonstrated to
improve outcome for patients with hormone-resistant metastatic breast cancer. Patients will
continue on the most recent hormonal therapy they received prior to entering this study.
It is hoped that trastuzumab alone, everolimus alone, or trastuzumab in combination with
everolimus, may cause your tumor to stop growing or possibly to cause your tumor to shrink.
This assessment will be based on measuring changes in the size of your tumor. You will be
requested to have a biopsy of one of your metastatic areas prior to study entry to measure
the amount of HER2/neu protein in your tumor.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Every 8 to 12 weeks
Ruth O'Regan, MD
Emory University Winship Cancer Institute
United States: Food and Drug Administration
|Emory University Winship Cancer Institute||Atlanta, Georgia 30322|