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 @ 9:45 PM
Ignite Modification Date:
2025-12-24 @ 9:45 PM
NCT ID:
NCT00045032
Eligibility Criteria:
Inclusion Criteria:
* Non-metastatic primary invasive breast cancer overexpressing HER2 (determined by immunohistochemistry 3+ or positive fluorescence in situ hybridization test) that has been histologically confirmed, adequately excised, axillary node positive or negative, and tumor size at least T1c according to Tumor/Node/Metastasis (TNM) staging
* Completion of at least 4 cycles of (neo-)adjuvant systemic chemotherapy, definitive surgery, and radiotherapy, if applicable
* Known hormone receptor status
* Baseline left ventricular ejection fraction (LVEF) greater than or equal to (≥) 55 percent (%)
Exclusion Criteria:
* Prior invasive breast carcinoma
* Other malignancies except for curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix
* Clinical T4 tumors
* Cumulative doxorubicin exposure greater than (\>) 360 milligrams per meter-squared (mg/m\^2) or epirubicin \>720 mg/m\^2 or any prior anthracyclines unrelated to the present breast cancer
* Peripheral stem cell or bone marrow stem cell support
* Prior mediastinal irradiation except for internal mammary node irradiation for the present breast cancer
* Non-irradiated internal mammary nodes or supraclavicular lymph node involvement
* Prior anti-HER2 therapy for any other reason or other prior biologic or immunotherapy for breast cancer
* Concurrent anti-cancer treatment in another investigational trial
* Serious cardiac or pulmonary conditions/illness, or any other conditions that could interfere with planned treatment
* Poor hematologic, hepatic, or renal function
* Pregnancy or lactation
* Women of childbearing potential or less than 1 year post-menopause unwilling to use adequate contraceptive measures
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00045032
Study Brief:
Protocol Section:
NCT00045032