Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-24 @ 11:02 PM
NCT ID:
NCT00509769
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent form.
* Human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC); tissue (slides or blocks) available for HER2 confirmation.
* History of progression on HER2-directed therapy for the treatment of HER2-positive breast cancer.
* At least 1, and no more than 3, chemotherapy regimens for MBC.
* Granulocyte count ≥ 1500/μL, platelet count ≥ 100,000/μL, and hemoglobin ≥ 9 g/dL.
* Serum bilirubin ≤ 1.5 mg/dL, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase ≤ 2.5x the upper limit of normal (ULN).
* Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 60 mL/min.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Exclusion Criteria:
* Any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biological therapy for the treatment of breast cancer within 2 weeks of the first study treatment.
* Prior cumulative doxorubicin dose \> 360 mg/m\^2 or the equivalent.
* History of significant cardiac disease, unstable angina, congestive heart failure (CHF), myocardial infarction, or ventricular arrythmia requiring medication.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00509769
Study Brief:
Protocol Section:
NCT00509769