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

Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00303615
• Other study ID #: 200.3540
• 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

• Breast Neoplasms
• Metastatic Breast Cancer

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