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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 1

Conditions

Breast Cancer

Treatments

Drug: dalotuzumab (MK0646)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00759785

2008-004180-18 (EudraCT Number)

MK-0646-013 (Other Identifier)

0646-013

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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