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

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

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.

Study Overview

• Status: Terminated
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Drug: Fluoxymesterone 10 mg; Drug: Anastrozole 1 mg

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to disease progression

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: Legacy Health System
• Investigators: Principal Investigator: Nathalie Johnson, MD, Good Samaritan Foundation

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (Anticipated): June 1, 2007
• Study Completion (Actual): July 1, 2007

Study Registration Dates

• First Submitted: March 16, 2006
• First Submitted That Met QC Criteria: March 16, 2006
• First Posted (Estimate): March 17, 2006

Study Record Updates

• Last Update Posted (Estimate): October 20, 2008
• Last Update Submitted That Met QC Criteria: October 17, 2008
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: ER (-) and PR (-)
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Anabolic Agents; Anastrozole; Fluoxymesterone
• Other Study ID Numbers: 200.3540