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 @ 3:36 PM
Ignite Modification Date:
2025-12-24 @ 3:36 PM
NCT ID:
NCT00856492
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or pathologically confirmed breast cancer meeting one of the following criteria:
* Locally advanced disease (stage IIIB disease, stage IIB/IIIA, or stage IIIC disease)
* Inflammatory disease meeting the following two clinicopathologic criteria:
* Diffuse erythema AND edema (peau d'orange) of the breast involving the majority of the skin of the breast, i.e., more than 50%
* A biopsy demonstrating cancer either within the dermal lymphatics OR in the breast parenchyma itself
* HER2/neu-negative tumor as demonstrated by 0 or 1+ (weak or no staining) by DAKO, IHC, or equivalent test OR no gene amplification by FISH\*
* 2+ by DAKO or IHC allowed provided FISH\* negative
* NOTE: \*A negative FISH test ratio is \< 1.8 or FISH HER2 gene copy \< 4.0; if only a positive or negative result is available from the FISH test, a negative result is acceptable for study entry
* Hormone receptor status known
PATIENT CHARACTERISTICS:
* Menopausal status not specified
* Zubrod performance status 0-2
* Granulocyte count \> 1,500/mm\^3
* ANC ≥ 1,500/mm\^3
* Platelet count \> 100,000/mm\^3
* Hemoglobin 9.0 g/dL
* Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
* Bilirubin ≤ 1.5 mg/dL
* ALT and AST ≤ 3 times ULN
* Alkaline phosphatase ≤ 2.5 ULN (unless bone metastasis is present in the absence of liver metastasis)
* Urine protein:creatinine ratio ≤ 0.5 OR urine protein \< 1,000 mg on 24-hour urine collection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to take oral medications (e.g., no uncontrolled nausea, vomiting, or diarrhea, lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome)
* QTc \< 500 msec by EKG
* LVEF normal by MUGA or ECHO (for patients with hypertension or for patients \> 60 years of age)
* NYHA class II cardiac function by baseline ECHO/MUGA (for patients who have received central thoracic radiotherapy that included the heart in the radiotherapy port, or for patients who have a history of class II heart failure but are asymptomatic on treatment are eligible)
* No history of stroke (cerebrovascular accident), transient ischemic attack, or cardiac event within the past 12 months, including any of the following:
* Myocardial infarction (including severe/unstable angina)
* Coronary/peripheral artery bypass graft
* Symptomatic congestive heart failure
* Pulmonary embolism
* No poorly controlled hypertension, defined as recurrent or persistent (≥ 24 hours) elevated blood pressure (i.e., systolic blood pressure ≥ 140 mm Hg and/or diastolic blood pressure ≥ 90 mm Hg)
* No other malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
* Peripheral neuropathy \< grade 2
PRIOR CONCURRENT THERAPY:
* No prior tyrosine kinase inhibitors
* More than 5 years since prior chemotherapy, radiotherapy, or biologic therapy (e.g., trastuzumab or bevacizumab) for invasive breast cancer
* At least 7 days since prior hormonal therapy
* At least 7 days since prior and no concurrent strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) or grapefruit juice
* No concurrent CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, St. John's wort)
* No other concurrent therapy for the treatment of breast cancer except for bisphosphonates
* No concurrent brachytherapy
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00856492
Study Brief:
Protocol Section:
NCT00856492