Everolimus in Treating Women With Breast Cancer That Can Be Removed by Surgery - Full Text View

Sponsors and Collaborators:	Masonic Cancer Center, University of Minnesota National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00855114

Purpose

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 Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: magnetic resonance imaging Procedure: magnetic resonance spectroscopic imaging Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer MRI Scans Surgery

Drug Information available for: Everolimus

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Decrease of total choline in at least 30% of patients [ Designated as safety issue: No ]

Secondary Outcome Measures:

Identification of response to everolimus by activated mTOR signaling [ Designated as safety issue: No ]
Functional biochemical response to therapy as measured by MRI/MRS [ Designated as safety issue: No ]

Estimated Enrollment:	38
Study Start Date:	July 2008
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

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.

Tertiary

Determine if non-invasive high field MRI and spectroscopy will identify a functional biochemical response to treatment with 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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
No intracranial disease
Hormone receptor status not specified

PATIENT CHARACTERISTICS:

Menopausal status not specified
ECOG performance status 0-1
ANC ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin > 9.0 g/dL
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
Not obese (> 250 pounds)
No immunosuppression from any cause (e.g., known HIV infection)
No history of severe asthma and/or allergies
No history of severe claustrophobia
No ferromagnetic implants, history of shotgun wound and/or shrapnel, cardiac pacemakers, or other similar situations that would be contrary to strong magnetic force
No bleeding diathesis
No 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

PRIOR CONCURRENT THERAPY:

More than 4 weeks since prior investigational drug
No prior therapy with sirolimus or its analogues
No concurrent immunosuppressive therapy (e.g., steroids, cytotoxic agents, or concurrent radiotherapy)
No concurrent anticoagulation (i.e., coumadin)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855114

Locations

United States, Minnesota
University of Minnesota Children's Hospital - Fairview
Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

Masonic Cancer Center, University of Minnesota

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Douglas Yee, MD

Masonic Cancer Center, University of Minnesota

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Masonic Cancer Center at University of Minnesota ( Douglas Yee )
Study ID Numbers:	CDR0000635715, UMN-2005LS029, 0505M70026
Study First Received:	March 3, 2009
Last Updated:	June 14, 2009
ClinicalTrials.gov Identifier:	NCT00855114 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

stage II breast cancer
stage III breast cancer
stage IIIA breast cancer

Study placed in the following topic categories:

Everolimus
Immunologic Factors
Skin Diseases

Breast Neoplasms
Immunosuppressive Agents
Breast Diseases

Additional relevant MeSH terms:

Everolimus
Neoplasms
Neoplasms by Site
Immunologic Factors
Skin Diseases

Physiological Effects of Drugs
Breast Neoplasms
Immunosuppressive Agents
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on September 11, 2009