Letrozole and Lapatinib Followed by Everolimus in Women With Advanced Breast Cancer
Status:
Terminated
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
About a third of patients with breast cancer are usually treated by hormone pills called
tamoxifen and aromatase inhibitors. Aromatase inhibitors are drugs that stop female hormone
production. Female hormone or estrogen is an important hormone for the growth of breast
cancer cells. Letrozole is one of the aromatase inhibitors that is approved by the FDA and
has been used to treat breast cancer since 1997. However, hormone pills usually work for
about 6-10 months in most patients. Later on, breast cancer will start to grow again. This
condition when hormone pills or endocrine therapy no longer work is called "endocrine
resistant" breast cancer. The scientists here at University of Maryland have discovered how
these cancer cells can become resistant to hormone pills. In our laboratory tests, the
investigators found that lapatinib and everolimus can reverse this resistance and make
letrozole work again. However, it is not known if the drugs can reverse the resistance in
humans.
The purpose of this study is to find out whether the combination of letrozole, lapatinib, and
everolimus is effective in women with breast cancer when hormone pills no longer work.
Lapatinib is an anti-cancer drug that is already approved by the Food and Drug Administration
(FDA). It is the standard of care for the treatment of a particular type of breast cancer
called human epithelial growth factor receptor 2 (HER2)-positive breast cancer. HER2 is a
protein involved in the growth of some cancer cells. This study will also include patients
with HER2-negative breast cancer. This means that the cancer cells in these patients do not
depend on the HER2 protein. The use of lapatinib in these patients is considered
experimental.
Everolimus is also an anti-cancer drug that is approved by the FDA for kidney cancer. Initial
studies in mice and later studies in women with breast cancer have shown that everolimus may
also slow the growth of breast cancer. The use of everolimus is experimental in this study.
Phase:
Phase 2
Details
Lead Sponsor:
University of Maryland University of Maryland, Baltimore