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