Open Label, Multicenter, Randomized, Controlled Study of IM or Oral Exemestane (Aromasin) in Postmenopausal Women With Advanced Breast Cancer Having Progressed on Tamoxifen.
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms
Female
Breast Neoplasms
Trial Information
Open Label, Multicenter, Randomized, Controlled Study of IM or Oral Exemestane (Aromasin) in Postmenopausal Women With Advanced Breast Cancer Having Progressed on Tamoxifen.
Inclusion Criteria:
- other diagnosed with breast cancer
- estrogen receptor positivity
- Postmenopausal status
- advanced disease
- progression to previous tamoxifen therapy
Exclusion Criteria:
- more than 1 chemotherapy and / or more than 1 hormonotherapy for advanced disease
- previous hormonotherapy other than Tamoxifen
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine the pharmacodynamic equivalence at steady state of the IM formulation of exemestane with the oral formulation in terms of plasma estrone sulphate inhibitory effect in postmenopausal women with advanced breast cancer.
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
971-ONC-0401-003
NCT ID:
NCT00040014
Start Date:
June 2002
Completion Date:
December 2006
Related Keywords:
- Breast Neoplasms
- Breast Neoplasms
- Neoplasms
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