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

This study has been terminated.
(Low accrural)
Sponsor:
Information provided by:
Legacy Health System
ClinicalTrials.gov Identifier:
NCT00303615
First received: March 16, 2006
Last updated: October 17, 2008
Last verified: October 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Metastatic Breast Cancer
 Drug: Fluoxymesterone 10 mg
Drug: Anastrozole 1 mg
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Androgen Therapy for Management of Estrogen/Progesterone Receptor Negative ER(-)PR(-) Metastatic Breast Cancer, Phase II Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Legacy Health System:

Primary Outcome Measures:
  • Time to disease progression

Secondary Outcome Measures:
  • 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

Enrollment: 5
Study Start Date: June 2005
Study Completion Date: July 2007
Estimated Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00303615

Locations
United States, Oregon
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, United States, 97210
Sponsors and Collaborators
Legacy Health System
Investigators
Principal Investigator: Nathalie Johnson, MD Good Samaritan Foundation
  More Information

No publications provided

Responsible Party: Nathalie Johnson, MD, Legacy Health System
ClinicalTrials.gov Identifier: NCT00303615     History of Changes
Other Study ID Numbers: 200.3540
Study First Received: March 16, 2006
Last Updated: October 17, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Legacy Health System:
ER (-) and PR (-)

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Androgens
Estrogens
Fluoxymesterone
Progesterone
Anastrozole
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anabolic Agents
Progestins
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013