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A Study to Establish Proof-of-Biology for MK0646 in Breast Cancer

Phase 1
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

A Study to Establish Proof-of-Biology for MK0646 in Breast Cancer

Inclusion Criteria:

- Patient has operable stage I-IIIa breast cancer of the following subtypes: (1)
ER-negative, PR-negative, and HER2-negative breast cancer; (2) ER-positive tumor
meeting one of the following criteria- histologic grade 3; histologic grade 2 and
PR-negative; histologic grade 2 and Ki67> 10%. Tumor is at least 2 cm in diameter as
assessed by physical or radiographic exam

- Patient is female and > 18 years of age

Exclusion Criteria:

- Patient is pregnant, breastfeeding or planning to become pregnant while in the study

- Patient has received prior chemotherapy, biological therapy or radiation

- Patient has participated in a clinical trial in the last 30 days

- Patient has a history of drug or alcohol abuse in the last year

- Patient is HIV positive. Patient has a history of Hepatitis B or C

- Patient has poorly controlled diabetes mellitus.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dalotuzumab will induce a decrease in the growth factor signature.

Outcome Time Frame:

Following single dose of study drug infused over 60 - 120 minutes

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

October 2008

Completion Date:

February 2010

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms