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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00303615
Other study ID # 200.3540
Secondary ID
Status Terminated
Phase Phase 2
First received March 16, 2006
Last updated October 17, 2008
Start date June 2005
Est. completion date July 2007

Study information

Verified date October 2008
Source Legacy Health System
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 5
Est. completion date July 2007
Est. primary completion date June 2007
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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:

- 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Fluoxymesterone 10 mg

Anastrozole 1 mg


Locations

Country Name City State
United States Legacy Good Samaritan Hospital and Medical Center Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
Legacy Health System

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to disease progression
Secondary Response of metastatic ER(-)PR(-) breast cancer to treatment with testosterone
Secondary Measure quality of life: improvement of fatigue in metastatic breast cancer patients
Secondary Measure degree of morbidity of treatment with testosterone in this setting
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