Study Of MK-0752 In Combination With Tamoxifen Or Letrozole to Treat Early Stage Breast Cancer (MK-0752)
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|ClinicalTrials.gov Identifier: NCT00756717|
Recruitment Status : Unknown
Verified April 2015 by Kathy Albain, Loyola University.
Recruitment status was: Active, not recruiting
First Posted : September 22, 2008
Last Update Posted : April 3, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: MK-0752||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||May 2008|
|Estimated Primary Completion Date :||May 2015|
|Estimated Study Completion Date :||May 2018|
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). [ 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00756717
|United States, Illinois|
|Loyola Univeristy Medical Center, Cardinal Bernardin Cancer Center|
|Maywood, Illinois, United States, 60153|
|Principal Investigator:||Kathy Albain, MD||Loyola University|