NCT00756717

Study Of MK-0752 In Combination With Tamoxifen Or Letrozole to Treat Early Stage Breast Cancer

A Pilot Study of MK-0752 in Combination With Tamoxifen or Letrozole in Patients With Early Stage Breast Cancer Prior to Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Loyola University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	MK-0752	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.

Timeline

• Start date: 2008-02-14
• Primary completion: 2011-12-21
• Completion: 2011-12-21
• First posted: 2008-09-22
• Last updated: 2019-09-04
• Results posted: 2019-09-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study