Breast Cancer Clinical Trial
Official title:
A Pilot Study of MK-0752 in Combination With Tamoxifen or Letrozole in Patients With Early Stage Breast Cancer Prior to Surgery
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.
OBJECTIVES
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.
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