Intermittent Letrozole Therapy in Postmenopausal Women With Metastatic Breast Cancer

PHASE2TerminatedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

May 31, 2010

Study Completion Date

September 30, 2013

Conditions
Breast Cancer
Interventions
DRUG

Letrozole

Treatment is intermittent with possible breaks between each 28 day treatment cycle if CA 15-3 or CA 27.29 level that has decreased by at least 50% of that individual patient's baseline or peak level on firstline letrozole or anastrozole therapy or has decreased into the normal reference range per institutional parameters. Letrozole or anastrozole therapy will be interrupted until CA 15-3 or CA 27.29 levels rise by at least 25% above trough CA 15-3 or CA 27.29 level. If the trough level is in the normal reference range then the CA 15-3 or CA 27.29 must rise into the normal reference range.

Trial Locations (2)

02115

Dana-Farber Cancer Institute, Boston

02215

Massachusetts General Hospital, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Dana-Farber Cancer Institute

OTHER

collaborator

Novartis

INDUSTRY

lead

Massachusetts General Hospital

OTHER