Status:
WITHDRAWN
Everolimus in Treating Women With Breast Cancer That Can Be Removed by Surgery
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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 w...
Detailed Description
OBJECTIVES: Primary * Determine whether the administration of everolimus results in a decrease of total choline, a surrogate marker of response, in at least 30% of women with resectable breast cance...
Eligibility Criteria
Inclusion
- Diagnosis of invasive breast cancer
- Resectable disease
- 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
- 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:
- Uncontrolled diabetes
- Severe infection
- Severe malnutrition
- Uncontrolled hypertension
- Unstable angina
- Ventricular arrhythmias
- Active ischemic heart disease
- Congestive heart failure
- Myocardial infarction within the past 6 months
- Chronic liver disease
- Renal disease
- Active upper gastrointestinal tract ulceration
- 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)
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00855114
Start Date
July 1 2008
End Date
June 1 2009
Last Update
December 2 2017
Active Locations (1)
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1
University of Minnesota Children's Hospital - Fairview
Minneapolis, Minnesota, United States, 55455