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About
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well everolimus works in treating women with breast cancer that can be removed by surgery.
Full description
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oral everolimus once daily on days 1-7 in the absence of disease progression or unacceptable toxicity. Within 24 hours after completing everolimus, patients undergo surgery.
Tumor tissue samples are collected at baseline and during surgery for the analysis of mTOR targets (i.e., 4E-BP1, p70S6 kinase phosphorylation), Ki67, cleaved caspase 3, and activity of cap dependent translational complex by immunohistochemical assays. Patients also undergo MRI/MRS before and after everolimus therapy for total choline and glucose levels measurement.
After completion of study therapy, patients are followed for 30 days.
Sex
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Volunteers
Inclusion criteria
Diagnosis of invasive breast cancer
Measurable disease, defined as a primary breast mass > 2.0 cm by breast imaging or clinical exam
Planning to undergo surgical resection after neoadjuvant therapy
Menopausal status not specified
Eastern Clinical Oncology Group (ECOG) performance status 0-1
Absolute neutrophil count (ANC) ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin > 9.0 g/dL
Aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≤ 2.5 times upper limit of normal (ULN)
Creatinine ≤ 1.5 times ULN
Total bilirubin ≤ 1.5 times ULN
Not pregnant
Negative pregnancy test
Fertile patients must use effective contraception
Exclusion criteria
Intracranial disease
Hormone receptor status not specified
Obese (> 250 pounds)
Immunosuppression from any cause (e.g., known HIV infection)
History of severe asthma and/or allergies
History of severe claustrophobia
Ferromagnetic implants, history of shotgun wound and/or shrapnel, cardiac pacemakers, or other similar situations that would be contrary to strong magnetic force
Bleeding diathesis
Unstable systemic disease, including but not limited to, any of the following:
Less than 4 weeks since prior investigational drug
Prior therapy with sirolimus or its analogues
Concurrent immunosuppressive therapy (e.g., steroids, cytotoxic agents, or concurrent radiotherapy)
Concurrent anticoagulation (i.e., coumadin)
Primary purpose
Allocation
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0 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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