Open Label, Multicenter, Randomized, Controlled Study of IM or Oral Exemestane (Aromasin) in Postmenopausal Women With Advanced Breast Cancer Having Progressed on Tamoxifen.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
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United States: Food and Drug Administration