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A Phase II Trial of Short-Term Everolimus (RAD001) to Predict Response in Women With Operable Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

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Trial Information

A Phase II Trial of Short-Term Everolimus (RAD001) to Predict Response in Women With Operable Breast Cancer



- 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

After completion of study therapy, patients are followed for 30 days.

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

- Concurrent anticoagulation (i.e., coumadin)

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Decrease of total choline in at least 30% of patients

Outcome Description:

Choline is measured by magnetic resonance imaging (MRI/MRS) scan.

Outcome Time Frame:

Pre-Treatment Compared to Post-Treatment (Day 7)

Safety Issue:


Principal Investigator

Douglas Yee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota


United States: Food and Drug Administration

Study ID:




Start Date:

July 2008

Completion Date:

June 2009

Related Keywords:

  • Breast Cancer
  • stage II breast cancer
  • stage III breast cancer
  • stage IIIA breast cancer
  • Breast Neoplasms



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