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 @ 3:54 PM
Ignite Modification Date:
2025-12-24 @ 3:54 PM
NCT ID:
NCT00513292
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of invasive adenocarcinoma by core needle biopsy
* Fine needle aspiration allowed provided primary tumor size \< 2 cm and lymph node metastases are present
* Excisional biopsy of the primary tumor allowed provided biopsy-positive lymph nodes are present
* Primary tumor ≥ 2 cm and/or ≥ 1 biopsy-positive lymph node
* HER2-positive disease
* Confirmation by fluorescent in situ hybridization (FISH) requires gene amplification
* Confirmation by immunohistochemistry (IHC) requires a strongly positive (3+) staining intensity score
* Ductal carcinoma in situ (DCIS) or synchronous DCIS of the contralateral breast regardless of prior therapy allowed
* Synchronous invasive breast cancer not allowed
* Ipsilateral DCIS treated by local excision with or without hormonal therapy allowed
* Those treated with radiation therapy are not allowed
* No definitive clinical or radiologic evidence of metastatic disease
* No history of invasive breast cancer
* Hormone receptor status known
* Menopausal status not specified
* ECOG performance status of 0 -1
* Absolute neutrophil count ≥ 1,200/mm³
* Platelet count ≥ 100,000/mm³
* Total bilirubin normal unless the patient has a grade 1 bilirubin elevation (normal to 1.5 times upper limit of normal \[ULN\]) resulting from Gilbert disease or similar syndrome due to slow conjugation of bilirubin
* Alkaline phosphatase ≤ 2.5 times ULN
* AST ≤ 1.5 times ULN
* Creatinine normal
* Left ventricular ejection fraction (LVEF) ≥ 55 by multi gated acquisition scan (MUGA) or echocardiogram (ECHO) within the past 3 months
* Patients with either skeletal pain or alkaline phosphatase that is \> ULN but ≤ 2.5 times ULN allowed if bone scans fail to demonstrate metastatic disease
* Suspicious findings on bone scan must be confirmed as benign by x-ray, MRI, or biopsy
* Prior non-breast malignancies allowed if disease-free for 5 years since completion of initial treatment regimen and deemed by their physician to be at low risk for recurrence
* Patients who had the following cancers are eligible if diagnosed and treated within the past 5 years:
* Carcinoma in situ of the cervix
* Colon carcinoma in situ
* Melanoma in situ
* Basal cell and squamous cell carcinoma of the skin
* No cardiac disease that would preclude the use of epirubicin hydrochloride or trastuzumab (Herceptin®) including any of the following:
* Active cardiac disease
* Angina pectoris that requires the use of antianginal medication
* Cardiac arrhythmia requiring medication
* Severe conduction abnormality
* Clinically significant valvular disease
* Cardiomegaly on chest x-ray
* Ventricular hypertrophy on EKG
* Patient's with poorly controlled hypertension ( i.e., diastolic greater than 100 mm/Hg)
* Patients with hypertension that is well controlled on medication are eligible
* History of cardiac disease
* Myocardial infarction documented as a clinical diagnosis or by EKG or any other tests
* Documented congestive heart failure
* Documented cardiomyopathy
* No sensory or motor neuropathy ≥ grade 2, as defined by the NCI's CTCAE v3.0
* Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy
* Women of child bearing potential must have a negative urine or serum pregnancy test within 2 weeks of registration
* Not pregnant or nursing
* No psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
* No non-malignant systemic disease (e.g., cardiovascular, renal, hepatic) that would preclude treatment with either of the treatment regimens
* No prior surgical axillary staging procedure
* Prior non-excisional biopsy of an axillary node allowed
* No prior treatment for this breast cancer
* Hormonal therapy allowed if had been given for up to a total of 28 days anytime after diagnosis and before study entry
* Hormonal therapy must stop at or before study entry and be re-started, if indicated, following surgery
* No prior therapy with anthracyclines or taxanes for any malignancy
* No other investigational agents within the past 30 days
* No concurrent sex hormonal therapy (e.g., birth control pills, ovarian hormonal replacement therapy)
* No concurrent therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulator (SERM), either for osteoporosis or breast cancer prevention
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00513292
Study Brief:
Protocol Section:
NCT00513292