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 @ 12:16 PM
Ignite Modification Date:
2025-12-24 @ 12:16 PM
NCT ID:
NCT00055861
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed breast cancer
* Local-regional recurrences or metastatic disease
* At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
* No history or evidence of CNS disease (e.g., primary brain tumor or any brain metastases)
* Hormone receptor status:
* Not specified
* Female
* Performance status - ECOG 0-2
* Performance status - Karnofsky 60-100%
* More than 3 months
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* No bleeding diathesis or coagulopathy
* Bilirubin normal
* AST/ALT no greater than 2.5 times upper limit of normal
* INR less than 1.5 (patients receiving warfarin)
* Creatinine normal
* Creatinine clearance at least 60 mL/min
* No baseline proteinuria
* Patients with proteinuria of 1+ or greater at baseline are allowed provided 24-hour urinary protein is less than 500 mg
* No symptomatic congestive heart failure
* No cardiac arrhythmia
* No uncontrolled hypertension
* No history of stroke
* No clinically significant peripheral artery disease
* No arterial thromboembolic event within the past 6 months, including any of the following:
* Transient ischemic attack
* Cerebrovascular accident
* Unstable angina
* Myocardial infarction
* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No seizures not controlled with standard medical therapy
* No prior allergic reactions attributed to compounds of similar chemical or biological composition to study agents
* No psychiatric illness or social situation that would preclude study compliance
* No ongoing or active infection
* No other concurrent uncontrolled illness
* No non-healing wounds
* No significant traumatic injury within the past 28 days
* Prior adjuvant chemotherapy allowed (up to 1 regimen for metastatic disease)
* More than 6 months since prior taxane-containing adjuvant chemotherapy
* More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
* More than 3 weeks since prior radiotherapy
* More than 28 days since prior major surgery or open biopsy
* More than 7 days since prior fine needle aspirations other than in the breast
* More than 7 days since prior placement of a vascular access device
* No concurrent major surgical procedure
* No concurrent or recent full-dose oral or parenteral anticoagulants or thrombolytic agents (except as required to maintain patency of preexisting, permanent indwelling IV catheters)
* No other concurrent investigational agents
* No concurrent chronic daily aspirin (more than 325 mg/day) or nonsteroidal anti-inflammatory medications (known to inhibit platelet function at doses used to treat chronic inflammatory diseases)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00055861
Study Brief:
Protocol Section:
NCT00055861