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 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT00524459
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed breast cancer using core biopsies
* Locally advanced disease
* Resectable disease
* Fine needle aspiration cytology allowed and must demonstrate invasive adenocarcinoma
* No more than 8 weeks since initial cytologic or histologic diagnosis of breast cancer
* Tumor must meet the following criteria:
* Palpable on clinical examination and confined to either the breast or to the breast and ipsilateral axilla
* Measured clinically as greater than 2 cm in size (T2)
* Patients with skeletal pain are eligible if bone scan and/or roentgenological examination fail to disclose metastatic disease
* Suspicious findings must be confirmed as benign by x-ray, MRI scan, or biopsy
* Hormonal status not specified
PATIENT CHARACTERISTICS:
Inclusion criteria:
* Female
* Menopausal status not specified
* ECOG performance status 0-2
* Life expectancy ≥ 10 years
* Platelet count ≥ 100,000/mm³
* ANC ≥ 1,500/mm³
* Hemoglobin ≥ 9.0 g/dL
* Bilirubin normal
* AST or ALT normal
* Alkaline phosphatase normal
* Serum creatinine normal
* Negative pregnancy test
* Fertile patients must use effective contraception (e.g., abstinence, intrauterine device, barrier device with spermicide, or surgical sterilization) during and for 3 months after completion of study therapy
* Normal cardiac function by LVEF or MUGA scan
* Patients with prior non-breast malignancies are eligible if they have been disease-free for ≥ 10 years
* The following are allowed even if diagnosed within the past 10 years:
* Squamous or basal cell carcinoma of the skin that has been effectively treated
* Carcinoma in situ of the cervix that has been treated by operation only
* Lobular carcinoma in situ of the ipsilateral or contralateral breast treated by segmental resection only
Exclusion criteria:
* Pregnant or lactating women
* Male patients
* Hyperbilirubinemia
* Female patients with 1 or more of the following conditions:
* Ulceration, erythema, infiltration of the skin (complete fixation), or peau d'orange (edema) of any magnitude
* Tethering or dimpling of the skin or nipple inversion should not be interpreted as skin infiltration
* Ipsilateral lymph nodes that are clinically fixed to one another or to other structures (N2 disease)
* Bilateral malignancy or a mass in the opposite breast suspicious for malignancy, unless there is biopsy proof that the mass is not malignant
* Suspicious palpable nodes in the contralateral axilla or palpable supraclavicular or infraclavicular nodes, unless there is biopsy evidence that these are not involved with the tumor
* Nonmalignant systemic disease (e.g., cardiovascular, renal, or hepatic) that would preclude study therapy
* Active cardiac disease that would preclude the use of doxorubicin hydrochloride, including any of the following:
* Documented myocardial infarction
* Angina pectoris that requires the use of antianginal medication
* History of documented New York Heart Association class II-IV heart failure
* Valvular disease with documented cardiac function compromise
* Poorly controlled hypertension (i.e., diastolic BP \> 100 mm Hg)
* Patients with well-controlled hypertension and on medication are eligible for study
* Psychiatric or addictive disorders that would preclude obtaining informed consent
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
* Concurrent noncancer therapies allowed if used for conditions other than breast cancer
* Adjuvant therapy after surgery allowed
Exclusion criteria:
* Prior radiotherapy, chemotherapy, immunotherapy, and/or hormonal therapy for breast cancer
* Prior anthracycline therapy for any condition
* Concurrent hormonal therapy including tamoxifen, aromatase inhibitors, or raloxifene
* Concurrent sex hormonal therapy including birth-control pills or ovarian hormonal replacement therapy
* Concurrent other cancer therapy
* Concurrent herbal or alternative therapies for breast cancer
Healthy Volunteers:
False
Sex:
FEMALE
Maximum Age:
64 Years
Study:
NCT00524459
Study Brief:
Protocol Section:
NCT00524459