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

• Status: Withdrawn
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: Female

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 well everolimus works in treating women with breast cancer that can be removed by surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Masonic Cancer Center, University of Minnesota
• Treatments: Everolimus; Sirolimus

Criteria

Inclusion Criteria:

• 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 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:

• 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)