NCT00855114

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2008

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

December 2, 2017

Status Verified

November 1, 2017

Enrollment Period

11 months

First QC Date

March 3, 2009

Last Update Submit

November 29, 2017

Conditions

Breast Cancer

Keywords

stage II breast cancerstage III breast cancerstage IIIA breast cancer

Outcome Measures

Primary Outcomes (1)

  • Decrease of total choline in at least 30% of patients

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

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

Secondary Outcomes (1)

  • Identification of response to everolimus by activated mTOR signaling

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

Study Arms (1)

Patients Treated with Everolimus

EXPERIMENTAL

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

Drug: everolimusProcedure: therapeutic conventional surgery

Interventions

everolimusDRUG

5 mg/day x 7 days by mouth

Also known as: RAD001, Afinitor(R)
Patients Treated with Everolimus
therapeutic conventional surgeryPROCEDURE

Definitive excision of breast cancer tissue

Also known as: surgery
Patients Treated with Everolimus

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota Children's Hospital - Fairview

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

EverolimusSurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Douglas Yee, MD

    Masonic Cancer Center, University of Minnesota

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2009

First Posted

March 4, 2009

Study Start

July 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

December 2, 2017

Record last verified: 2017-11

Locations

US(1)