Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022087
Status:
COMPLETED
Last Update Posted:
2016-07-19
First Post:
2001-08-10
Brief Title:
Zoledronate Calcium and Vitamin D in Preventing Bone Loss in Women Receiving Adjuvant Chemotherapy for Breast Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase III Trial of Intravenous Zoledronic Acid Zometa in the Prevention of Bone Loss in Localized Breast Cancer Patients With Chemotherapy-Induced Ovarian Failure
Status:
COMPLETED
Status Verified Date:
2016-07
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 plus calcium and vitamin D may prevent bone loss in patients receiving adjuvant chemotherapy for breast cancer It is not yet known which regimen is more effective in preventing bone loss
PURPOSE This randomized phase III trial is comparing two regimens of zoledronate plus calcium and vitamin D to see how well they work in preventing bone loss in women who are receiving adjuvant chemotherapy for breast cancer
PURPOSE This randomized phase III trial is comparing two regimens of zoledronate plus calcium and vitamin D to see how well they work in preventing bone loss in women who are receiving adjuvant chemotherapy for breast cancer
Detailed Description:
OBJECTIVES
Compare the bone mineral density in the lumbar spine after 12 and 36 months of therapy with zoledronate calcium and cholecalciferol vitamin D in women with breast cancer receiving adjuvant chemotherapy
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to intent to treat with tamoxifen yes vs no and node status negative vs positive vs unknown for patients receiving neoadjuvant therapy Patients are randomized to 1 of 2 treatment arms
Arm I Beginning on the first day of adjuvant chemotherapy or within 3 months after the first day patients receive zoledronate IV over at least 15 minutes once every 3 months during months 1-24 and oral calcium and oral cholecalciferol vitamin D daily during months 1-36
Arm II Beginning on the first day of adjuvant chemotherapy or within 3 months after the first day patients receive oral calcium and oral vitamin D daily during months 1-36 and zoledronate IV over at least 15 minutes once every 3 months during months 13-36
PROJECTED ACCRUAL Approximately 400 patients 200 per treatment arm will be accrued for this study within 24 months
Compare the bone mineral density in the lumbar spine after 12 and 36 months of therapy with zoledronate calcium and cholecalciferol vitamin D in women with breast cancer receiving adjuvant chemotherapy
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to intent to treat with tamoxifen yes vs no and node status negative vs positive vs unknown for patients receiving neoadjuvant therapy Patients are randomized to 1 of 2 treatment arms
Arm I Beginning on the first day of adjuvant chemotherapy or within 3 months after the first day patients receive zoledronate IV over at least 15 minutes once every 3 months during months 1-24 and oral calcium and oral cholecalciferol vitamin D daily during months 1-36
Arm II Beginning on the first day of adjuvant chemotherapy or within 3 months after the first day patients receive oral calcium and oral vitamin D daily during months 1-36 and zoledronate IV over at least 15 minutes once every 3 months during months 13-36
PROJECTED ACCRUAL Approximately 400 patients 200 per treatment arm will be accrued for this study within 24 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000068781 | REGISTRY | NCI Physicians Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CALGB-79809 | None | None | None |
| NCI-P01-0184 | None | None | None |