Clinical Research Details
Title:
Phase III Randomized Trial of Anastrozole vs. Anastrozole and Fulvestrant as First-Line Therapy for PostMenopausal Women with Metastatic Breast Cancer
Purpose:
The study seeks to compare the time to tumor progession in postmenopausal women with metastatic breast cancer treated with anastrozole vs. anastrozole and fulvestrant as first-line therapy.
Study Number:
LU 107418
Number of Patients:
690
Elgibility:
Participants must be women with a confirmed diagnosis of metastatic breast cancer or multiple sites of new disease that is clinically obvious metstatic disease. Participants also must be postmenopausal and have tumors that are estrogen and/or progestrone receptor-positive along with having measurable or non-measurable disease.
Treatment:
Patients will be randomly assigned to one of two groups. Patients in group one will receive anastrozole by mouth once a day. Patients in group two will receive anastrozole by mouth once a day plus an injection of fulvestrant in weeks one, two and four during the first course and then once every four weeks during any future courses. Treatment in both groups may continue for as long as benefit is shown. Patients will be evaluated for up to four years.
Principal Investigator:
Enrollment Phone:
(708) 327-3222