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


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

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


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.


Inclusion Criteria:



- Patients must have histologically or cytologically confirmed early stage,
ER-positive (Allred score ≥3), invasive breast cancer that is not either locally
advanced by criteria other than size or inflammatory, and is not metastatic. -
Patients must be candidates for surgical removal of the tumor by lumpectomy or
mastectomy.

- Patients must not have bilateral tumors. Tumor must be amenable to core biopsy in
midstudy.

- Patients must be >18 years of age.

- Patients must have a performance status ≤1 by Zubrod criteria.

- Patients must have a life expectancy of greater than three months.

- Patients must have normal organ and marrow function within 28 days of registration as
defined below:

- absolute neutrophil count >1,500/μL

- platelets >100,000/μL

- total bilirubin ≤1.5 x the institutional upper limit of normal

- AST(SGOT)/ALT(SGPT) <2 X institutional upper limit of normal

- creatinine within normal institutional limits OR

- creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels
above institutional normal

- Women of child-bearing potential must agree to use adequate contraception (hormonal
or barrier method of birth control; abstinence) prior to study entry and for the
duration of study participation. A negative serum pregnancy test must be obtained
within 72 hours of receiving the first dose of the hormonal therapy as well as within
72 hours of the first dose of the MK-0752 GSI medication for women of child-bearing
potential. Should a woman become pregnant or suspect she is pregnant while
participating in this study, she should inform her treating physician immediately.

Exclusion Criteria:

- Patients may not have received any prior chemotherapy or endocrine therapy
(tamoxifen, raloxifene, or an aromatase inhibitor) and may not have received prior
therapy with a gamma-secretase inhibitor or other investigational agents. -
Patients may not have received previous radiation therapy.

- Patients may not be currently participating or have participated in a study with an
investigational compound or device within 30 days.

- Patients must not have known brain or CNS disease, evidence of brain or CNS
metastases, or carcinomatous meningitis.

- Patients must not have an uncontrolled intercurrent illness including, but not
limited to, ongoing or active infection, symptomatic congestive heart failure,
unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social
situations that would limit compliance with study requirements.

- Patients may not have known hypersensitivity to the components of MK-0752 or it
analogs.

- Patients will be excluded if there is a known history of human immunodeficiency (HIV)
virus infection, or a known history of hepatitis B or C infection.

- Patients must not have a previous history of inflammatory bowel disease or
uncontrolled irritable bowel syndrome.

- Patients must not have a history of greater than one basal cell carcinoma of the skin
within the past five years or a history of Gorlin syndrome.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

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).

Outcome 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.

Safety Issue:

Yes

Principal Investigator

Kathy Albain, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Loyola University

Authority:

United States: Food and Drug Administration

Study ID:

200431

NCT ID:

NCT00756717

Start Date:

May 2008

Completion Date:

January 2012

Related Keywords:

  • Breast Cancer
  • MK-0752
  • Tamoxifen
  • Letroxole
  • Breast Neoplasms

Name

Location

Loyola Univeristy Medical Center, Cardinal Bernardin Cancer CenterMaywood, Illinois  60153