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 @ 2:44 PM
Ignite Modification Date:
2025-12-24 @ 2:44 PM
NCT ID:
NCT00675259
Eligibility Criteria:
Inclusion:
* Histologically confirmed breast cancer
* Clinically or radiographically measurable residual tumor after core biopsy
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Age ≥18 yrs
* Absolute neutrophil count ≥ 1,500/mm³
* Hemoglobin ≥ 9 g/dL
* Platelet count ≥ 100,000/ mm³
* Creatinine ≤ 1.5 times upper limit of normal (ULN)
* Urine protein:creatinine ratio \< 1.0
* AST (aspartate aminotransferase) and ALT ≤ 2.5 times ULN
* Alkaline phosphatase ≤ 2.5 times ULN
* Bilirubin normal
* Women of childbearing potential must use effective contraception
* Left ventricular ejection fraction (LVEF) normal by echocardiogram or MUGA
Exclusion:
* No residual tumor after initial biopsy
* Peripheral neuropathy of grade 2 or higher
* HER-2 neu overexpression either by IHC 3+ or FISH+
* No history of any prior treatment of breast cancer.
* No history of unstable angina or myocardial infarction within the past 12 months
* Pregnant or nursing women
* Anticoagulation therapy within the last 6 months
* History of gastrointestinal bleeding
* Recent hemoptysis
* No known hepatitis B or HIV seropositivity
* No inadequately controlled hypertension, defined as systolic blood pressure (BP) \> 150 mm Hg and/or diastolic BP \> 100 mm Hg despite antihypertensive medications
* History of hypertensive crisis or hypertensive encephalopathy
* New York Heart Association class II-IV congestive heart failure
* History of stroke or transient ischemic attack at any time
* Significant vascular disease (e.g., aortic aneurysm or aortic dissection)
* No symptomatic peripheral vascular disease
* Evidence of bleeding diathesis or coagulopathy
* Significant traumatic injury within the past 28 days
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
* Serious, non-healing wound, ulcer, or bone fracture
* Known hypersensitivity to any component of bevacizumab
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00675259
Study Brief:
Protocol Section:
NCT00675259