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

This study has been withdrawn prior to enrollment.
(Withdrawn due to no accrual)
ClinicalTrials.gov Identifier:
First Posted: March 4, 2009
Last Update Posted: February 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Masonic Cancer Center, University of Minnesota

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.

Condition Intervention Phase
Breast Cancer Drug: everolimus Procedure: therapeutic conventional surgery Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Short-Term Everolimus (RAD001) to Predict Response in Women With Operable Breast Cancer

Resource links provided by NLM:

Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:
  • Decrease of total choline in at least 30% of patients [ Time Frame: Pre-Treatment Compared to Post-Treatment (Day 7) ]
    Choline is measured by magnetic resonance imaging (MRI/MRS) scan.

Secondary Outcome Measures:
  • Identification of response to everolimus by activated mTOR signaling [ Time Frame: Pre-Treatment Compared to Post-Surgery (Day 7) ]
    Two core biopsies will be obtained at the time of diagnostic biopsy. Waste tumor tissue obtained during surgery will be collected at the time of surgery. It will be stored under liquid nitrogen until they can be examined for activation of mTOR targets, specifically, 4E-BP1, p70S6 kinase phosphorylation, and activity of cap dependent translational complex.

Enrollment: 0
Study Start Date: July 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients Treated with Everolimus
Breast cancer patients treated with Everolimus by mouth, 5 mgs/day x 7 days, followed by surgery.
Drug: everolimus
5 mg/day x 7 days by mouth
Other Names:
  • RAD001
  • Afinitor(R)
Procedure: therapeutic conventional surgery
Definitive excision of breast cancer tissue
Other Name: surgery

Detailed Description:



  • 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 cancer.


  • Determine whether tumors with activated mTOR signaling, as measured by phosphorylation of 4E-BP1 and activity of cap dependent translational complex, will identify those women responsive to everolimus.

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.


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00855114

United States, Minnesota
University of Minnesota Children's Hospital - Fairview
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Principal Investigator: Douglas Yee, MD Masonic Cancer Center, University of Minnesota
  More Information

Responsible Party: Douglas Yee, Masonic Cancer Center at University of Minnesota
ClinicalTrials.gov Identifier: NCT00855114     History of Changes
Other Study ID Numbers: 2005LS029
0505M70026 ( Other Identifier: IRB, University of Minnesota )
First Submitted: March 3, 2009
First Posted: March 4, 2009
Last Update Posted: February 19, 2016
Last Verified: February 2016

Keywords provided by Masonic Cancer Center, University of Minnesota:
stage II breast cancer
stage III breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents