Yükleniyor... / Loading...
This study evaluates the drug Dalotuzumab (MK-0646) in patients with operable Stage I-IIIa breast cancer. It included women over 18 with specific subtypes (triple-negative or certain hormone receptor-positive tumors) at least 2 cm in size. It was a Phase 1 study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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