11
Participants
Start Date
July 31, 1999
Primary Completion Date
July 31, 2003
Study Completion Date
August 31, 2008
Raloxifene followed by combination therapy
Patients will be randomized to either Raloxifene at 60mg P.O. (each day) for 2 weeks (time designated: week- 2) After two weeks of single agent therapy, patients will be started on combination therapy with oral raloxifene (60mg/day) and oral exemestane (25mg/day) (time designated week 0), and continued on both drugs for one year (month 12). Patients will be required to start supplemental calcium (900-1500 mg/day) plus vitamin D (400-600 units/day) P.O. each day during week 0.
Exemestane followed by combination therapy
Patients will be randomized to Exemestane at 25mg P.O. for 2 weeks (time designated: week- 2) After two weeks of single agent therapy, patients will be started on combination therapy with oral raloxifene (60mg/day) and oral exemestane (25mg/day) (time designated week 0), and continued on both drugs for one year (month 12). Patients will be required to start supplemental calcium (900-1500 mg/day) plus vitamin D (400-600 units/day) P.O. each day during week 0.
Memorial Sloan-Kettering Cancer Center, New York
Collaborators (1)
Pharmacia
INDUSTRY
Memorial Sloan Kettering Cancer Center
OTHER