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 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT00404404
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed invasive breast cancer
* Recurrent or metastatic disease OR locally recurrent disease not amenable to resection with curative intent
* Measurable or nonmeasurable disease
* No CNS metastases by CT scan or MRI
* No HER2-neu-positive tumors
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Female
* Menopausal status not specified
* Performance status 0-1
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count \> 100,000/mm³
* Creatinine \< 2.0 mg/dL
* Bilirubin normal
* AST ≤ 2 times upper limit of normal (ULN) (5 times ULN if there is known liver involvement)
* Urine protein:creatinine ratio \< 1.0 OR proteinuria \< 2+ by urine dipstick OR ≤ 1 g protein on 24-hour urine collection
* No peripheral neuropathy \> grade 1
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other malignancies within the past 5 years except carcinoma in situ of the cervix, melanoma in situ, or basal cell carcinoma of the skin
* No inadequately controlled hypertension, defined as systolic blood pressure (BP) \> 150 mm Hg and/or diastolic BP \> 100 mm Hg on antihypertensive medications
* No prior hypertensive crisis or hypertensive encephalopathy
* No New York Heart Association class II-IV congestive heart failure
* No myocardial infarction or unstable angina within the past 6 months
* No stroke or transient ischemic attack within the past 6 months
* No significant vascular disease (e.g., aortic aneurysm or aortic dissection)
* No symptomatic peripheral vascular disease
* No evidence of bleeding diathesis or coagulopathy
* No significant traumatic injury within the past 28 days
* No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
* No serious, nonhealing wound, ulcer, or bone fracture
* No known hypersensitivity to any component of bevacizumab
PRIOR CONCURRENT THERAPY:
* No prior paclitaxel albumin-stabilized nanoparticle formulation (ABI-007; Abraxane\^®) or bevacizumab
* No prior chemotherapy for metastatic disease
* Prior hormonal therapy for metastatic disease allowed
* At least 4 weeks since any prior therapy for cancer
* More than 12 months since prior adjuvant chemotherapy, including use of a taxane
* More than 28 days since prior major surgery or open biopsy
* More than 7 days since prior core biopsy or minor surgery (excluding placement of a vascular access device)
* No concurrent major surgery
* No other concurrent therapy for breast cancer
* Concurrent bisphosphonates allowed if there is bone involvement
* No concurrent prophylactic granulocyte colony-stimulating factors
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00404404
Study Brief:
Protocol Section:
NCT00404404