Status:
TERMINATED
Androgen Therapy for Management of Estrogen/Progesterone Receptor Negative ER(-)PR(-) Metastatic Breast Cancer
Lead Sponsor:
Legacy Health System
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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 ther...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00303615
Start Date
June 1 2005
End Date
July 1 2007
Last Update
October 20 2008
Active Locations (1)
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1
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, United States, 97210