Everolimus in Treating Women With Breast Cancer That Can Be Removed by Surgery

Withdrawn before enrolling · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00855114

Run by

Masonic Cancer Center, University of Minnesota

People needed

0

Starts

2008-07-01

Expected to finish

2009-06-01

Last updated by the study team

2017-12-02

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• University of Minnesota Children's Hospital - Fairview — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.