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 @ 2:17 PM
Ignite Modification Date:
2025-12-24 @ 2:17 PM
NCT ID:
NCT00431795
Eligibility Criteria:
Inclusion Criteria:
* Age 18-75 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Adequate bone marrow function (Absolute neutrophil count \>1000/mm\^3, Platelet count\>100000/mm\^3, Hemoglobin\>9gr/mm\^3)
* Histologically- or cytologically- confirmed breast adenocarcinoma
* No prior anthracycline-based chemotherapy as treatment of advanced breast cancer
* No prior chemotherapy with ≥ 300mg/m2 doxorubicin or ≥ 540mg/m2 epirubicin as adjuvant setting
* At least 4 weeks interval since prior anticancer treatment
* Measurable disease as defined by the presence of at least one measurable lesion(except bone metastases, ascites or pleural effusions)
* Life expectancy \> 3 months
* Written informed consent
Exclusion Criteria:
* Pregnancy or nursing
* Documented history of congestive heart failure (CHF), serious arrhythmia, or myocardial infarction (within 6 months)
* Other invasive malignancy except nonmelanoma skin cancer or acute infection.
* Radiation of measurable disease (except brain metastases)
* Progressive brain metastases according to clinical or radiological criteria.
* Brain metastases without prior radiation therapy
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00431795
Study Brief:
Protocol Section:
NCT00431795