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TerminatedNCT00303615Updated Oct 20, 2008

Androgen Therapy for Management of Estrogen/Progesterone Receptor Negative ER(-)PR(-) Metastatic Breast Cancer

A Phase 2 interventional study of Fluoxymesterone 10 mg and Anastrozole 1 mg in Metastatic Breast Cancer, sponsored by Legacy Health System. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-10-20.

Sponsored by Legacy Health System · Phase 2, Interventional, and Treatment

Why this study was terminated
Low accrural
Phase
Phase 2
Study type
Interventional
Enrollment
5
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Metastatic Breast Cancer

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Keywords

  • ER (-) and PR (-)
03

In context

Breast Neoplasms

12,820 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's enrollment of 5 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Legacy Health System is the lead sponsor of 31 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Interventions

06

What researchers measure

Primary outcomes

  1. Time to disease progression

Secondary outcomes

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

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

  3. Measure degree of morbidity of treatment with testosterone in this setting

07

Study locations

1 site
  • Legacy Good Samaritan Hospital and Medical Center
    Portland, Oregon 97210, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2005, a primary completion of Jun 2007 and a completion of Jul 2007. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 16, 2006
First posted
Mar 17, 2006
Start
Jun 2005
Primary completionEst.
Jun 2007
CompletionActual
Jul 2007
Last update
Oct 20, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 20, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00303615
Lead sponsor
Legacy Health System
First posted
Mar 17, 2006
Start date
Jun 2005
Primary completion
Jun 2007 (estimated)
Completion
Jul 2007
Last update
Oct 20, 2008

Study contacts

Nathalie Johnson, MD
principal investigator · Good Samaritan Foundation
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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