A Study of Dalotuzumab (MK-0646) in Breast Cancer Patients (MK-0646-013)

• Status: Completed
• Trial end date: 2010-02-17
• Target enrollment: 0
• Participant gender: Female

Summary

A study to evaluate the response of growth factor signatures (GFS) to a single dose of dalotuzumab in participants with triple negative (TN) or estrogen receptor (ER)-positive luminal B breast cancer. The primary hypothesis is that dalotuzumab will induce a decrease in the GFS in at least 40% of participants.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• Participant has operable stage I-IIIa breast cancer of the following subtypes: (1) estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and human epidermal growth factor receptor 2 (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 antigen ≥10%. Tumor is at least 2 cm in diameter as assessed by physical or radiographic exam

• Participant is female and ≥18 years of age

Exclusion Criteria:

• Participant is pregnant, breastfeeding or planning to become pregnant while in the study

• Participant has received prior chemotherapy, biological therapy or radiation

• Participant has participated in a clinical trial in the last 30 days

• Participant has a history of drug or alcohol abuse in the last year

• Participant is human immunodeficiency virus (HIV) positive. Patient has a history of Hepatitis B or C

• Participant has poorly controlled diabetes mellitus