Zoledronate in Treating Bone Marrow Micrometastases in Women With Stage I, Stage II, or Stage III Breast Cancer
- Registration Number
- NCT00295867
- Lead Sponsor
- University of California, San Francisco
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
Primary
* 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.
Secondary
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 45
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Zoledronic Acid Zoledronic Acid Patients women with early stage breast cancer and evidence of occult malignant cells in bone marrow aspirates following adjuvant chemotherapy will receive zoledronic acid (Zometa) 4mg, given intravenously over 15 minutes, once a month for two years.
- Primary Outcome Measures
Name Time Method Response of Bone Marrow Micrometastases up to 2 years Median change in disseminated tumor cells (DTCs)/mL from baseline after 24 months
- Secondary Outcome Measures
Name Time Method Change in N-telopeptide Level up to 2 years N-telopeptide levels in urine will be recorded to evaluate the effect of zoledronic acid on bone mineralization (nmol bone collagen equivalents/mmol creatinine) at baseline and after 24 months on study treatment
Number of Patients With Incidences of Distant Recurrence up to 5 years post initiation of treatment Distant breast cancer recurrence is when the cancer has spread to another organ within the body.
Trial Locations
- Locations (1)
University of California, San Francisco
🇺🇸San Francisco, California, United States