A Phase II, Randomized, Double-Blinded Efficacy and Safety Study of Three Doses of TAS-108 Administered Orally in Postmenopausal Patients With Locally Advanced or Locally Recurrent Inoperable or Progressive Metastatic Breast Cancer Following Standard First-Line Endocrine Therapy
The objective of this study is to investigate the efficacy and safety of TAS-108
administered in postmenopausal patients with locally advanced or locally recurrent
inoperable or progressive metastatic breast carcinoma who have previously responded to one
or two standard endocrine therapies, with or without one prior chemotherapy.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
To evaluate the safety of TAS-108 administered on this schedule
James N. Ingle, M.D.
United States: Food and Drug Administration
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