Trial of RAD001 in Triple Negative Metastatic Breast Cancer
The hypothesis of this clinical research study is to discover if the study drug RAD001 can shrink or slow the growth of Estrogen Receptor/Progesterone Receptor (ER/PR) negative or Human Epidermal growth factor Receptor 2 (Her2 Neu) negative breast cancer. The safety of RAD001 will also be studied. Patients physical state, symptoms, changes in the size of the tumor, and laboratory findings obtained while on-study will help the research team decide if RAD001 is safe and effective.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of RAD001 in Triple Negative Metastatic Breast Cancer|
- Time to Progression(TTP) [ Time Frame: Each patient assessed at 8 weeks from start of study drug ] [ Designated as safety issue: No ]Progression is defined by RESIST criteria as any new lesion or the sum of target lesions increasing by 20% over baseline
- Progression Free Survival (PFS): Defined as the Time From Registration to Progression or to Death From Any Cause Without Documentation of Progression [ Time Frame: 6 months ] [ Designated as safety issue: No ]Not applicable, as data will not be presented
|Study Start Date:||April 2009|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Experimental: RAD 001
RAD001-10 mg by mouth once everyday
Drug: RAD 001
RAD 001-10 mg by mouth once everyday
Other Name: Everolimus
RAD001 is an orally administered cell cycle inhibitor with antitumor activity. RAD001, like Rapamycin, binds with high affinity to an intracellular immunophilin, FKBP12 and this complex specifically interacts with the mammalian target of rapamycin (mTOR) protein kinase, inhibiting downstream events such as the initiation of mRNA translation. RAD001 inhibits the growth of a wide range of histologically diverse tumor cells. RAD001 is being developed as a cytostatic agent to delay the time to tumor recurrence/progression or to increase survival in patients with various malignancies. The compound has good tolerability, a partially discovered mechanism of action. RAD001 has the ability to arrest cells in the G1 phase, and the ability to induce apoptosis. RAD001 is being investigated as an anticancer agent based on its potential to act directly on the tumor cells by inhibiting tumor cell growth and proliferation through possible inhibition of the PI3/AKT/MTOR pathway.
RAD001 was shown to have activity in human tumor cell lines originating from lung, breast, prostate, colon, kidney, melanoma and glioblastoma. RAD001 was also shown to have activity in human pancreatic neuroendocrine cells, where induction of apoptosis was reported, as well as in acute myeloid leukemia cells, adult T-cell leukemia cells, diffuse large B cell lymphoma cells, pancreatic tumor cells, ovarian cancer cells, and hepatocellular carcinoma cells.
|United States, Pennsylvania|
|Penn State Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||Allan Lipton, MD||Penn State Milton S. Hershey|