Status:
COMPLETED
A Study of Dalotuzumab (MK-0646) in Breast Cancer Patients (MK-0646-013)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief 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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 30 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2010
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00759785
Start Date
September 30 2008
End Date
February 17 2010
Last Update
August 15 2018
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