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

Primary Purpose

Breast Cancer

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
everolimus
therapeutic conventional surgery
Sponsored by
Masonic Cancer Center, University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage II breast cancer, stage III breast cancer, stage IIIA breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Minnesota Children's Hospital - Fairview

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients Treated with Everolimus

Arm Description

Breast cancer patients treated with Everolimus by mouth, 5 mgs/day x 7 days, followed by surgery.

Outcomes

Primary Outcome Measures

Decrease of total choline in at least 30% of patients
Choline is measured by magnetic resonance imaging (MRI/MRS) scan.

Secondary Outcome Measures

Identification of response to everolimus by activated mTOR signaling
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.

Full Information

First Posted
March 3, 2009
Last Updated
November 29, 2017
Sponsor
Masonic Cancer Center, University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT00855114
Brief Title
Everolimus in Treating Women With Breast Cancer That Can Be Removed by Surgery
Official Title
A Phase II Trial of Short-Term Everolimus (RAD001) to Predict Response in Women With Operable Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Withdrawn due to no accrual
Study Start Date
July 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masonic Cancer Center, University of Minnesota

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage II breast cancer, stage III breast cancer, stage IIIA breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients Treated with Everolimus
Arm Type
Experimental
Arm Description
Breast cancer patients treated with Everolimus by mouth, 5 mgs/day x 7 days, followed by surgery.
Intervention Type
Drug
Intervention Name(s)
everolimus
Other Intervention Name(s)
RAD001, Afinitor(R)
Intervention Description
5 mg/day x 7 days by mouth
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Other Intervention Name(s)
surgery
Intervention Description
Definitive excision of breast cancer tissue
Primary Outcome Measure Information:
Title
Decrease of total choline in at least 30% of patients
Description
Choline is measured by magnetic resonance imaging (MRI/MRS) scan.
Time Frame
Pre-Treatment Compared to Post-Treatment (Day 7)
Secondary Outcome Measure Information:
Title
Identification of response to everolimus by activated mTOR signaling
Description
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.
Time Frame
Pre-Treatment Compared to Post-Surgery (Day 7)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Yee, MD
Organizational Affiliation
Masonic Cancer Center, University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota Children's Hospital - Fairview
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

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

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