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 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT00290732
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed infiltrating carcinoma of the breast meeting any of the following criteria:
* T1-3, any N disease
* Proven ductal carcinoma in situ
* Unresected disease
* Planned mastectomy as definitive surgical procedure
* Known or suspected metastatic disease allowed provided mastectomy is planned
* Nonpalpable tumor allowed (e.g., initial T2-3 tumor that responded to preoperative therapy)
* No inflammatory breast cancer or other T4 features
* Successful baseline ductogram
* Baseline nipple aspiration procedure must identify a duct productive of nipple aspirate fluid
* No severe nipple retraction
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Female patients
* Menopausal status not specified
* ECOG performance status 0-2
* Absolute neutrophil count ≥1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9.0 g/dL
* Creatinine ≤ 2 times upper limit of normal (ULN)
* Bilirubin ≤ 2 times ULN
* AST and ALT ≤ 2.5 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No significant history of severe allergy to iodinated contrast material or debilitating anxiety that may not allow for a ductogram
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Prior preoperative chemotherapy, trastuzumab (Herceptin®), or hormonal therapy allowed provided it was completed 7-14 days prior to study treatment
* No prior radiation therapy, excisional biopsy, breast reduction, areolar surgery, or breast implant (present or past history of implant that was removed)
* No other prior procedure that may have altered the breast ductal system in the ipsilateral breast
* No other concurrent chemotherapy, radiotherapy, endocrine therapy, or biologic agents for breast cancer
* No other concurrent investigational drugs
* Concurrent bisphosphonates allowed
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00290732
Study Brief:
Protocol Section:
NCT00290732