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:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT00017394
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed stage IV breast cancer
* Patients without pathologic or cytologic confirmation of metastatic disease must have unequivocal evidence of metastasis by physical exam or radiologic study
* Must meet 1 of the following criteria:
* Received 1 or 2 prior conventional chemotherapy regimens for metastatic disease
* Relapsed within 1 year after adjuvant chemotherapy and no prior chemotherapy for metastatic disease
* At least 1 unidimensionally measurable lesion, meeting 1 of the following criteria:
* At least 20 mm by conventional techniques
* At least 10 mm by spiral CT scan
* No CNS metastases by CT scan or MRI within the past 6 weeks
* No prior or concurrent primary CNS tumor on physical exam
* Disease progression after bone marrow or peripheral blood stem cell transplantation allowed
* HER2-positive tumors allowed if previously treated with trastuzumab (Herceptin)
* Hormone receptor status:
* Not specified
* Male or female
* Performance status - ECOG 0-2
* Performance status - Karnofsky 60-100%
* More than 3 months
* Absolute neutrophil count at least 1,500/mm\^3
* Hemoglobin at least 9 g/dL
* Platelet count at least 100,000/mm\^3
* No prior bleeding diathesis or coagulopathy
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST/ALT no greater than 2.5 times ULN
* INR no greater than 1.5
* Creatinine less than 2 mg/dL
* Urine protein no greater than +1 by dipstick
* Urine protein less than 500 mg by 24-hour urine collection
* LVEF at least 50%
* No prior stroke
* No New York Heart Association class II-IV congestive heart failure
* No serious cardiac arrhythmia requiring medication, including atrial fibrillation requiring systemic anticoagulation
* No grade II or greater peripheral vascular disease within the past year
* No clinically significant peripheral artery disease
* No deep vein thrombosis or embolism within the past 5 years
* No arterial thromboembolic event within the past 6 months, including any of the following:
* Transient ischemic attack
* Cerebrovascular accident
* Unstable angina
* Myocardial infarction
* No other significant cardiovascular disease
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No evidence of seizures not controlled with standard medical therapy
* No prior allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab or other agents used in the study
* Prior mild infusion reaction to trastuzumab allowed
* No serious non-healing wound, ulcer, or bone fracture
* No significant traumatic injury within the past 4 weeks
* No other concurrent illness (such as active infection) that would require active treatment or preclude study
* No psychiatric illness or social situation that would preclude study
* See Disease Characteristics
* No prior bevacizumab
* No other prior experimental angiogenesis inhibitors
* At least 2 weeks since prior trastuzumab and recovered
* Concurrent epoetin alfa or filgrastim (G-CSF) allowed
* See Disease Characteristics
* At least 2 weeks since prior chemotherapy and recovered
* No prior vinorelbine
* No more than 2 prior conventional chemotherapy regimens for metastatic breast cancer
* Prior hormonal therapy allowed
* At least 1 week since prior radiotherapy and recovered
* No concurrent radiotherapy
* At least 4 weeks since prior major surgical procedure or open biopsy
* At least 1 week since prior fine-needle aspiration except in the breast
* No concurrent major surgical procedure
* Recovered from the toxic effects of any prior therapy
* At least 10 days since prior oral or parenteral anticoagulants (e.g., heparin or warfarin) except to maintain the patency of permanent, indwelling central venous catheter
* At least 10 days since prior thrombolytic agents
* No chronic aspirin therapy greater than 325 mg per day or non-steroidal anti-inflammatory medications that inhibit platelet function
* No concurrent COX-2 inhibitors that inhibit platelet function
* No other concurrent investigational or commercial agents or therapies for the malignancy
* No concurrent antiretroviral therapy for HIV-positive patients
* No concurrent ketoconazole, zidovudine, or macrolide antibiotics
* No concurrent oral or parenteral anticoagulants except to maintain patency of permanent, indwelling central venous catheter
* No concurrent thrombolytic agent
* Concurrent bisphosphonates allowed
* Concurrent celecoxib or rofecoxib allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00017394
Study Brief:
Protocol Section:
NCT00017394