A Phase II Clinical Trial of Intermittent Letrozole Therapy in Postmenopausal Women With CA 15-3 Positive, Hormone Receptor Positive, Metastatic Breast Cancer
- This study involves treating participants with intermittent AI therapy. The AI will be
stopped at the time they enter the study. We plan on monitoring a marker in the
participants blood called CA 15-3 (or CA 27.29) every 4 weeks to help us make a
decision of when to re-start treatment with letrozole (femara). This marker is known
to rise when disease is progressing and drop when the disease is responding to
treatment. We will be stopping and re-starting therapy based on the changes of CA 15-3
in the participants blood.
- In addition to bloodwork, the following tests and procedures will be performed on a
monthly basis: medical history; physical examination and performance status.
- Every 8 weeks the following will be performed: Tumor assessment by physical exam (if
possible); Chest x-ray or CT scan or chest; CT scans of abdomen and pelvis; and bone
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the proportion of patients who have a decline in serum CA 15-3 once letrozole therapy has been reintroduced after a drug free observation phase.
Paul Goss, MD, PhD
Massachusetts General Hospital
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|