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 @ 6:43 PM
Ignite Modification Date:
2025-12-24 @ 6:43 PM
NCT ID:
NCT00532857
Eligibility Criteria:
Inclusion Criteria:
* All patients must have histologically confirmed and newly diagnosed operable breast cancer
* HER2 positive (all FISH +)
* Axillary node positive (by PET or cytologically determine node by sonography) and/or tumor size \> 5 cm -No prior hormonal, chemotherapy or radiotherapy is allowed.
* No breast operation other than biopsy to make diagnosis is allowed.
* Age: 18-years and older, not pregnant pre-, and postmenopausal women with good performance status (ECOG 0-1)
* Adequate hematopoietic function:
Absolute granulocyte count ³1500/mm3,
* platelet ³100,000/mm3, Hemoglobin ³ 10 g/mm3
* Adequate renal function: Serum creatinine £ 1.5 mg/dl
* Adequate hepatic function: total bilirubin: £ 1.5 mg/dl, AST/ALT: £ 2 times normal, Alkaline phosphatase: £ 2 times normal-Adequate cardiac function:
1. normal or nonspecific EKG taken within 1 mo of enrollment
2. LVEF ³ 50% by MUGA or Echocardiogram taken within 1 mo of enrollment
* Normal mental function to understand and sign the consent
Exclusion Criteria:
* patients who received hormonal, chemotherapy or radiotherapy for breast cancer
* patients who underwent surgery for breast cancer
* patients with a history of uncompensated congestive heart failure
* 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
80 Years
Study:
NCT00532857
Study Brief:
Protocol Section:
NCT00532857