Study Of MK-0752 In Combination With Tamoxifen Or Letrozole to Treat Early Stage Breast Cancer (MK-0752)
The purpose of this research project is to study the effect of a research (investigational) drug, MK-0752 combined with either tamoxifen or letrozole on breast cancer cells.
Tamoxifen and letrozole are standard hormone treatments used to treat breast cancers that are positive for the estrogen receptor. However, over time the breast cancer cells can become resistant to tamoxifen and letrozole. MK-0752 is in a class of drugs called gamma secretase inhibitors. Gamma secretase inhibitors may play a role in reversing the resistance to drugs such as tamoxifen and letrozole.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A Pilot Study of MK-0752 in Combination With Tamoxifen or Letrozole in Patients With Early Stage Breast Cancer Prior to Surgery|
- To evaluate the safety and tolerability of the gamma-secretase inhibitor MK-0752 in the pre-surgical setting in patients with early stage, estrogen receptor (ER) positive breast cancer, in combination with tamoxifen or an aromatase inhibitor (AI). [ Time Frame: Treatment will be given over a 24 day period. Toxcity assessments will be done on or around day 15, day 25 and at the post surgical visit. ]
- To establish the feasibility and success of multi-laboratory collaborations in evaluating clinical specimens and biomarker testing [ Time Frame: Completion of study ]
- To provide preliminary data on the impact of MK-0752 on the panel of biomarkers under investigation. [ Time Frame: Completion of study ]
|Study Start Date:||May 2008|
|Estimated Study Completion Date:||May 2018|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
oral gamma-secretase inhibitor drug MK-0752, 350 mg for three days, four days off, then three days on, over a period of 10 days
Women who are post menopausal will receive letrozole 2.5 mg by mouth one time per day for 24 days. Women who are pre menopausal, or who have a contraindication to letrozole will receive tamoxifen 20 mg orally one time per day for a period of 24 days. Starting on day 15 of this 24 day period all patients will receive the oral gamma-secretase inhibitor drug MK-0752 at a dose of 350 mg for three days on, then off four days, then three days on, for a total of 6 doses over a period of 10 days.
To evaluate the safety and tolerability of the gamma-secretase inhibitor MK-0752 in the pre-surgical setting in patients with early stage, estrogen receptor (ER) positive breast cancer, in combination with tamoxifen or an aromatase inhibitor (AI).
To establish the feasibility and success of multi-laboratory collaborations in evaluating clinical specimens and biomarker testing.
To provide preliminary data on the impact of MK-0752 on a panel of biomarkers involved in the notch signaling pathway.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00756717
|United States, Illinois|
|Loyola Univeristy Medical Center, Cardinal Bernardin Cancer Center|
|Maywood, Illinois, United States, 60153|
|Principal Investigator:||Kathy Albain, MD||Loyola University|