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


Phase 2
18 Years
N/A
Not Enrolling
Female
Metastatic Breast Cancer

Thank you

Trial Information

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to disease progression

Principal Investigator

Nathalie Johnson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Good Samaritan Foundation

Authority:

United States: Institutional Review Board

Study ID:

200.3540

NCT ID:

NCT00303615

Start Date:

June 2005

Completion Date:

July 2007

Related Keywords:

  • Metastatic Breast Cancer
  • ER (-) and PR (-)
  • Breast Neoplasms

Name

Location

Legacy Good Samaritan Hospital and Medical CenterPortland, Oregon  97210