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:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
NCT ID:
NCT01133912
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed and newly diagnosed operable breast cancer
* Documented HER2 positive disease : 3+ overexpression by IHC or HER2 gene amplification by FISH
* ECOG performance status 0-2
* Age ≥ 18 years
* Clinical stage II or III operable breast cancer
* Axillary node positivity determined by cytology
* No prior hormonal, chemotherapy, or radiotherapy is allowed
* No breast operation other than biopsy to make diagnosis is allowed
* Negative urine pregnancy test within 7 days prior to registration in premenopausal patients
* Adequate hematopoietic function: Absolute granulocyte count ≥1,500/mm3, platelet ≥100,000/mm3, hemoglobin ≥10g/mm3
* Adequate hepatic function: total bilirubin ≤1.5mg/dL, AST/ALT ≤2 x UNL, alkaline phosphatase ≤2 x UNL
* Adequate renal function: Serum creatinine ≤1.5mg/dL
* Adequate cardiac function:
1. Normal or nonspecific EKG taken within 1 month of enrollment
2. LVEF ≥50% by MUGA or echocardiogram taken within 4 weeks of enrollment
* Ability to understand and comply with protocol during study period
* Patients should sign a written informed consent before study entry
Exclusion Criteria:
* Pregnant or lactating women
* Patients who received hormonal, chemotherapy or radiotherapy for breast cancer
* Patients with bilateral breast cancer
* Patients who underwent surgery for breast cancer
* Patients with node-negative stage IIA (T2N0) breast cancer
* Patients who have history of cancer other than in situ uterine cervix cancer or nonmelanotic skin cancer
* Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled GI disease (e.g., Crohn's disease, ulcerative colitis)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01133912
Study Brief:
Protocol Section:
NCT01133912