Zoledronate in Treating Bone Marrow Micrometastases in Women With Stage I, Stage II, or Stage III Breast Cancer
RATIONALE: Zoledronate may delay or prevent bone marrow metastases in patients with breast cancer.
PURPOSE: This phase II trial is studying how well zoledronate works in treating bone marrow micrometastases in women with stage I, stage II, or stage III breast cancer.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||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|
- Response of bone marrow micrometastases [ Time Frame: up to 2 years post initiation of treatment ] [ Designated as safety issue: No ]
- Effects of zoledronic acid on n-telopeptide [ Time Frame: up to 2 years post initiation of treatment ] [ Designated as safety issue: No ]
- Incidence of distant recurrence [ Time Frame: up to 5 years post initiation of treatment ] [ Designated as safety issue: No ]
|Study Start Date:||December 2005|
|Estimated Study Completion Date:||December 2013|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
- 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.
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115-1710|
|Principal Investigator:||Hope S. Rugo, MD||University of California, San Francisco|