Trial | NCT00303615  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    5
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 Started
Jun 30
2005
Primary Completion
Jun 30
2007
Anticipated
Study Completion
Jul 31
2007
Last Update
Oct 20
2008
Estimate

Drug Fluoxymesterone 10 mg

Drug Anastrozole 1 mg

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
No Results Posted