Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00295867
Status:
COMPLETED
Last Update Posted:
2020-05-12
First Post:
2006-02-23
Brief Title:
Zoledronate in Treating Bone Marrow Micrometastases in Women With Stage I Stage II or Stage III Breast Cancer
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 immunocytochemistryflow cytometry ICFC 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
Primary
Determine the response of bone marrow micrometastases as measured by immunocytochemistryflow cytometry ICFC 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10-01674 | OTHER | University of California San Francisco | None |
| UCSF-H6961-24352-02 | OTHER | None | None |