NCT00303615

Brief Summary

This study is for patients with breast cancer that has spread to other tissues and organs. The purpose of this study is to identify patients who may respond favorably to certain types of hormonal therapy. Researchers will study your tumor, which was removed during your breast surgery. They will look for the presence or absence of Androgen (AR) receptors. These tests are for research purposes only. They will not affect the treatment of your breast cancer. The presence or absence of Androgen receptors on the tumor does not alter the therapy that is offered to patients. Recent evidence suggests that AR+ tumors are more likely to be destroyed when treated with androgen drugs. We will ask about 35 ER-/PR- breast cancer patients from Legacy Health System to be in this study. All tests and procedures are done as an outpatient in the doctor's office, a clinic, or at the hospital. The study drug that will be used in this trial is Androxy®, a synthetic androgen hormone. Androgens have been shown to inhibit the growth of some breast cancer cells. Arimidex is an aromatase inhibitor that will be used in conjunction with Androxy to inhibit the in vivo production of estrogen. It is hoped that the combination of these two drugs will inhibit the growth of your tumor and possibly cause it to shrink.

Trial Health

57
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Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2005

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

October 20, 2008

Status Verified

October 1, 2008

Enrollment Period

2 years

First QC Date

March 16, 2006

Last Update Submit

October 17, 2008

Conditions

Metastatic Breast Cancer

Keywords

ER (-) and PR (-)

Outcome Measures

Primary Outcomes (1)

  • Time to disease progression

Secondary Outcomes (3)

  • Response of metastatic ER(-)PR(-) breast cancer to treatment with testosterone

  • Measure quality of life: improvement of fatigue in metastatic breast cancer patients

  • Measure degree of morbidity of treatment with testosterone in this setting

Interventions

Anastrozole 1 mgDRUG
Fluoxymesterone 10 mgDRUG

Eligibility Criteria

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

You may qualify if:

  • Over 18 years of age
  • ER Negative and PR Negative
  • Progression of disease in the metastatic setting despite taxane or other chemotherapeutic therapies including Herceptin (patients on Herceptin may continue this therapy while on study)
  • Maximized chemotherapy in the metastatic setting or patient experienced side effects contributing to decreased quality of life and elects to defer chemotherapy
  • Evaluable disease by either:
  • CT Scan with or without contrast (lesions must be greater than 2 mm)
  • PET Scan, or Bone Scan, or Plain skeletal films
  • Chest wall or skin recurrence (digital photo to capture evaluable disease)
  • Evaluable symptoms (pain, shortness of breath, fatigue, anorexia)
  • Performance Status of 0, 1, or 2
  • Bilateral mammogram performed within one year before registration

You may not qualify if:

  • Uncontrolled hypercalcemia greater than 11
  • Uncontrolled congestive heart failure greater than 2 NYHA class
  • Central Nervous System metastasis
  • Concomitant steroid use
  • Performance Status of greater than 2
  • Bilirubin greater than 5.5

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, 97210, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

FluoxymesteroneAnastrozole

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AndrostenediolsAndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedNitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Nathalie Johnson, MD

    Good Samaritan Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 16, 2006

First Posted

March 17, 2006

Study Start

June 1, 2005

Primary Completion

June 1, 2007

Study Completion

July 1, 2007

Last Updated

October 20, 2008

Record last verified: 2008-10

Locations

US(1)