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 @ 2:05 PM
Ignite Modification Date:
2025-12-24 @ 2:05 PM
NCT ID:
NCT00934895
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed breast cancer
* Locally recurrent or metastatic disease
* Not amenable to surgery or radiotherapy
* HER2/neu-negative disease
* Has ≥ 1 measurable lesion, as defined by RECIST criteria
* No non-measurable lesions (e.g., pleural effusion or ascites) other than bone metastases
* Bone metastases as the sole site of disease allowed provided there are ≥ 2 lytic bone lesions by x-ray, CT scan, or MRI
* Lesions irradiated in the advanced setting are not considered sites of measurable disease unless clear tumor progression has been documented in these lesions since the completion of radiotherapy
* No bilateral diffuse lymphangitis carcinomatosa of the lung (\> 50% of lung involvement) or evidence of liver metastases estimated as involving \> one third of the liver by sonogram and/or CT scan
* No unstable CNS metastases
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Menopausal status not specified
* ECOG performance status 0-2
* Life expectancy ≥ 3 months
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin \> 9 g/dL
* Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
* ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN in patients with liver metastases)
* INR \< 1.5 times ULN
* Serum creatinine ≤ 1.5 mg/dL
* Fasting serum cholesterol ≤ 300 mg/dL (or 7.75 mmol/L) (levels outside this threshold allowed provided statin therapy is initiated)
* Fasting triglycerides ≤ 2.5 times ULN (levels outside this threshold allowed provided statin therapy is initiated)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Oral, implantable, or injectable contraceptives are not considered effective contraception
* No ascites or encephalopathy due to liver disease
* No neuropathy ≥ grade 2
* No impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of everolimus, including any of the following:
* Ulcerative disease
* Uncontrolled nausea, vomiting, or diarrhea
* Malabsorption syndrome
* No active, bleeding diathesis
* No known HIV seropositivity
* No known hypersensitivity to everolimus or sirolimus (rapamycin), paclitaxel albumin-stabilized nanoparticle formulation, or lactose
* No history of noncompliance to medical regimens
* No severe and/or uncontrolled medical condition or other condition that could affect study participation, including any of the following:
* Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within the past 6 months, or serious uncontrolled cardiac arrhythmia
* Severely impaired lung function
* Active (acute or chronic) or uncontrolled infections or disorders
* Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by study treatment
* Liver disease (e.g., cirrhosis, chronic active hepatitis, or chronic persistent hepatitis)
* No other malignancies within the past 5 years, except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
* Prior systemic endocrine therapy for advanced breast cancer allowed
* No prior chemotherapy for advanced breast cancer
* Prior adjuvant chemotherapy allowed
* No prior small bowel resection
* More than 5 days since prior strong CYP3A inhibitors or inducers (e.g., rifabutin, rifampin, clarithromycin, ketoconazole, itraconazole, voriconazole, ritonavir, or telithromycin)
* More than 30 days since prior radiotherapy and recovered (alopecia allowed)
* Prior localized radiotherapy for analgesic purposes allowed provided radiotherapy has been completed and the patient's condition is stabilized
* No prior radiotherapy to ≥ 25% of the bone marrow
* More than 30 days since prior investigational drugs
* More than 1 week since prior and no concurrent immunization with attenuated live vaccines
* No concurrent oral anti-vitamin K medication, except low-dose coumadin
* No concurrent systemic steroids or other immunosuppressive agents as chronic therapy
* Topical applications, inhaled sprays, eye drops, or local injections allowed
* A short duration (\< 2 weeks) of systemic corticosteroids allowed
* No concurrent hormone replacement therapy, topical estrogens (including any intra-vaginal preparations), megestrol acetate, or selective estrogen-receptor modulators (e.g., raloxifene)
* No other concurrent investigational or anticancer agents
* Concurrent antiangiogenic agents allowed
* Concurrent bisphosphonates allowed
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00934895
Study Brief:
Protocol Section:
NCT00934895