Eligibility Module

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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 @ 3:50 PM
Ignite Modification Date: 2025-12-24 @ 3:50 PM
NCT ID: NCT00003992
Eligibility Criteria: DISEASE CHARACTERISTICS: * Histologically confirmed stage II or IIIa (T1-T3, N1-N2, M0) adenocarcinoma of the breast HER2 overexpression (2-3+ by immunochemistry) * Bilateral breast cancer allowed * Must have had local breast cancer surgery within past 12 weeks * Mastectomy or lumpectomy with clear surgical margins AND axillary lymph node dissection with at least 6 nodes removed * Hormone receptor status: Not specified PATIENT CHARACTERISTICS: * Age: 18 and over * Sex: Female * WBC at least 3,000/mm3 * Platelet count at least 100,000/mm3 * Hemoglobin at least 9 g/dL * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * Creatinine no greater than 1.5 times ULN * LVEF at least 50% * No history of congestive cardiomyopathy * No congestive heart failure or myocardial infarction within the past 6 months * No uncontrolled hypertension * No uncontrolled arrhythmia within the past 6 months * No other prior malignancy within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix * No other serious medical illness that would limit survival to less than 2 years * No psychiatric condition precluding study * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * No prior chemotherapy for breast cancer * No prior hormonal therapy for breast cancer * At least one year since prior tamoxifen for chemoprevention (e.g., Breast Cancer Prevention Trial) * No prior radiotherapy to the breast, chest wall, or regional lymph nodes
Healthy Volunteers: False
Sex: FEMALE
Minimum Age: 18 Years
Study: NCT00003992
Study Brief:
Protocol Section: NCT00003992