Combined Estrogen Blockade of the Breast With Exemestane and Raloxifene in Postmenopausal Women With a History of Breast Cancer Who Have No Clinical Evidence of Disease

NACompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

July 31, 1999

Primary Completion Date

July 31, 2003

Study Completion Date

August 31, 2008

Conditions
Breast Cancer
Interventions
DRUG

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.

DRUG

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.

Trial Locations (1)

10021

Memorial Sloan-Kettering Cancer Center, New York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pharmacia

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER