Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT00295867
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.
Study:
NCT00295867
Study Brief:
Protocol Section:
NCT00295867