Pilot Study to Evaluate the Effect of Zoledronic Acid (Zometa) on Occult Malignant Bone Marrow Cells in Patients With High Risk Early Stage Breast Cancer
- Determine the response of bone marrow micrometastases, as measured by
immunocytochemistry/flow cytometry (IC/FC), during and after 2 years of treatment with
zoledronate in women with stage I-III breast cancer.
- Evaluate the effects of zoledronate on the bone osteoclast activation marker,
n-telopeptide, in these patients.
- Evaluate the incidence of distant recurrences in high-risk women with early-stage
breast cancer and bone marrow micrometastases who receive adjuvant zoledronate.
OUTLINE: This is a pilot study.
Patients receive zoledronate IV over 15 minutes once a month for 2 years in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label
Response of bone marrow micrometastases
up to 2 years post initiation of treatment
Hope S. Rugo, MD
University of California, San Francisco
United States: Federal Government
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|