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 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT00544505
Eligibility Criteria:
Inclusion Criteria:
Disease Characteristics:
* Palpable, operable breast cancer that has been diagnosed by core needle biopsy (mandatory for T1c tumors) or fine needle aspiration within 21 days prior to entry
* Stage T1c-4b, N0-1, M0
Hormone receptor status:
* Not specified
* No bilateral breast cancer
Prior/Concurrent Therapy:
* No previous treatment for breast cancer
Biologic therapy:
* Not specified
Chemotherapy:
* No previous chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* Core needle biopsy or fine needle aspiration within 21 days prior to entry
* Repeated core needle biopsy permitted
Patient Characteristics:
Age:
* 16 to 70
Sex:
* Women only
Menopausal status:
* Not specified
Performance status:
* WHO 0-2
Hematopoietic:
* WBC at least 4,000
* Platelets at least 100,000
Hepatic:
* Bilirubin no greater than 2.8 mg/dL (50 micromoles/L)
Renal:
* Creatinine no greater than 1.3 mg/dL (120 micromoles/L)
Cardiovascular:
* No congestive heart failure
* No significant arrhythmia
* No bilateral bundle branch block
* No recent myocardial infarction
* No uncontrolled hypertension (diastolic pressure greater than 110 mm Hg)
Other:
* No male breast cancer
* No pregnant or nursing women
* No second malignancy except adequately treated:
* Nonmelanomatous skin cancer
* Cervical cancer
Healthy Volunteers:
False
Sex:
FEMALE
Maximum Age:
70 Years
Study:
NCT00544505
Study Brief:
Protocol Section:
NCT00544505