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 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT00455533
Eligibility Criteria:
Inclusion criteria
* Histologically confirmed primary invasive adenocarcinoma of the breast , T2-3, N0-3, M0, with tumor size of ≥ 2 cm
* All patients with early stage breast adenocarcinoma may enroll irrespective of receptor status
* No prior treatment for breast cancer excluding therapy for DCIS
* Karnofsky performance status of 80 - 100
* left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram or multiple gated acquisition (MUGA)
* Adequate hematologic, hepatic and renal function
Exclusion Criteria
* women of child-bearing potential (WOCBP) unwilling or unable to use an acceptable method to avoid pregnancy during and up to 8 weeks after the last dose of the investigational drug
* Women who are pregnant or breastfeeding
* Inflammatory or metastatic breast cancer
* Unfit for breast and/or axillary surgery
* Evidence of baseline sensory or motor neuropathy
* Significant history of cardiovascular disease, serious intercurrent illness or infections including known human immu immunodeficiency virus (HIV) infection
* History of prior anthracycline therapy Allergies to any study medication or Cremophor® EL
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00455533
Study Brief:
Protocol Section:
NCT00455533