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

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ClinicalTrials.gov Identifier: NCT00303615
Recruitment Status : Terminated (Low accrural)
First Posted : March 17, 2006
Last Update Posted : October 20, 2008
Sponsor:
Information provided by:
Legacy Health System

March 16, 2006
March 17, 2006
October 20, 2008
June 2005
June 2007   (Final data collection date for primary outcome measure)
Time to disease progression
- Time to disease progression
Complete list of historical versions of study NCT00303615 on ClinicalTrials.gov Archive Site
  • 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
  • - 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
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Metastatic Breast Cancer
  • Drug: Fluoxymesterone 10 mg
  • Drug: Anastrozole 1 mg
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
35
July 2007
June 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00303615
200.3540
Not Provided
Not Provided
Not Provided
Nathalie Johnson, MD, Legacy Health System
Legacy Health System
Not Provided
Principal Investigator: Nathalie Johnson, MD Good Samaritan Foundation
Legacy Health System
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP