Study of Fulvestrant +/- Everolimus in Post-Menopausal, Hormone-Receptor + Metastatic Breast Ca Resistant to AI
Status:
Completed
Trial end date:
2017-09-12
Target enrollment:
Participant gender:
Summary
Post-menopausal women with hormone-receptor positive (HR+) metastatic breast cancer resistant
to aromatase inhibitor (AI) therapy will be randomized to receive Fulvestrant (Faslodex) with
Everolimus or Fulvestrant (Faslodex) with a placebo (no active ingredients).
Fulvestrant has demonstrated activity when used as first, second, or third line endocrine
therapy, making it an attractive therapy for combination with other agents. In addition, it
is commonly reserved for use following disease progression on AI therapy.
Everolimus is an orally administered drug that blocks a signaling pathway called "mTOR".
"mTOR" acts as a regulator for many processes in the body, including cell growth. Blocking
this pathway may have an effect on cell growth.
The combination of a novel class of agents (mTOR inhibitors) and an established standard
treatment for metastatic HR+ breast cancer may potentially increase the clinical benefit by
targeting multiple different biological pathways.