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 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT00754351
Eligibility Criteria:
Inclusion Criteria:
* Histologically- or cytologically- confirmed metastatic breast adenocarcinoma
* No HER2 overexpression or gene amplification
* At least one previous chemotherapy regimen for metastatic breast cancer
* Age ≥18 years
* Performance status (WHO) 0-2
* Life expectancy of at least 12 weeks
* Measurable disease as defined by at least 1 bidimensionally measurable lesion ≥ 20 X 10 mm
* Performance status (WHO) 0-2
* Adequate liver function (serum bilirubin \<1.5 times the upper normal limit, AST and ALT \<2.5 times the upper normal limit in the absence of demonstrable liver metastases, or \<5 times the upper normal limit in the presence of liver metastases), adequate renal function (serum creatinine \<1.5 times the upper normal limit) and bone marrow ≥ 1,500/mm3, PLT ≥ 100,000/mm3, Hgb ≥ 9 g/dL) function
* Written informed consent
Exclusion Criteria:
* Pregnant or lactating women
* Progressive brain metastases according to clinical or radiological criteria
* Brain metastases without prior radiation therapy
* Radiation therapy within the previous 4 weeks
* Previous radiation therapy to the only measurable lesion
* Proteinuria ≥ 500 mgr of protein daily
* Uncontrolled hypertension
* Documented hemorrhagic diathesis or coagulation disorder
* Cardiovascular disease (class II-IV NYHA congestive heart failure, myocardial infarction within the previous 4 months, unstable angina, LVEF \< normal, ventricular arrhythmia, uncontrolled hypertension)
* Thrombotic event within the previous 6 months
* Concurrent use of aspirin \> 325 mgr daily, low molecular weight heparin in therapeutic dose, warfarin or acenocoumarol, non-steroid anti-inflammatory agents
* Major surgical procedure within the previous 4 weeks
* Presence of nonhealing wound or fracture
* Peripheral neuropathy \> grade 2 according to the NCI CTCAE (version 3.0)
* Any sustained chronic toxicity \> grade 2 according to the NCI CTCAE (version 3.0)
* Uncontrolled infection
* Any serious, uncontrolled comorbidity on the investigator's judgment
* Other cancer within the previous 5 years, except non-melanoma skin cancer and in situ cervical cancer
* Serious psychiatric illness
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00754351
Study Brief:
Protocol Section:
NCT00754351