Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107263
Status:
COMPLETED
Last Update Posted:
2016-12-06
First Post:
2005-04-05
Brief Title:
Zoledronate in Preventing Bone Loss in Postmenopausal Women Who Are Receiving Letrozole for Stage I Stage II or Stage IIIA Breast Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Randomized Controlled Open-Label Trial of Empiric Prophylactic vs Delayed Use of Zoledronic Acid for Prevention of Bone Loss in Postmenopausal Women With Breast Cancer Initiating Therapy With Letrozole After Tamoxifen
Status:
COMPLETED
Status Verified Date:
2016-12
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 Estrogen can cause the growth of breast cancer cells Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes Zoledronate may prevent bone loss in patients who are receiving letrozole It is not yet known which schedule of zoledronate is more effective in preventing bone loss in patients with breast cancer
PURPOSE This randomized phase III trial is studying two different schedules of zoledronate to compare how well they work in preventing bone loss in postmenopausal women who are receiving letrozole for stage I stage II or stage IIIA breast cancer
PURPOSE This randomized phase III trial is studying two different schedules of zoledronate to compare how well they work in preventing bone loss in postmenopausal women who are receiving letrozole for stage I stage II or stage IIIA breast cancer
Detailed Description:
OBJECTIVES
Compare the effectiveness of zoledronate vs standard care in reducing bone loss during the first 12 months of study treatment in postmenopausal women with stage I-IIIA breast cancer initiating letrozole after prior treatment with tamoxifen
Compare the effect of immediate vs delayed zoledronate annually at 2-5 years post-baseline in reducing bone loss in these patients
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to duration of prior tamoxifen therapy 2 years vs 2 years time since tamoxifen therapy was discontinued 1 vs 1 year prior adjuvant chemotherapy yes vs no and baseline total lumbar spine or femoral neck bone mineral density BMD T-score -1 standard deviation SD vs between -1 to -2 SD Patients are randomized to 1 of 2 treatment arms
Arm I immediate therapy Patients receive oral letrozole once daily Patients also receive zoledronate IV over 15 minutes once every 6 months
Arm II delayed therapy Patients receive oral letrozole as in arm I Patients with radiologic evidence of bone loss after 1 year of letrozole therapy receive zoledronate as in arm I
In both arms treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 550 patients 275 per treatment arm will be accrued for this study within 28 months
Compare the effectiveness of zoledronate vs standard care in reducing bone loss during the first 12 months of study treatment in postmenopausal women with stage I-IIIA breast cancer initiating letrozole after prior treatment with tamoxifen
Compare the effect of immediate vs delayed zoledronate annually at 2-5 years post-baseline in reducing bone loss in these patients
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to duration of prior tamoxifen therapy 2 years vs 2 years time since tamoxifen therapy was discontinued 1 vs 1 year prior adjuvant chemotherapy yes vs no and baseline total lumbar spine or femoral neck bone mineral density BMD T-score -1 standard deviation SD vs between -1 to -2 SD Patients are randomized to 1 of 2 treatment arms
Arm I immediate therapy Patients receive oral letrozole once daily Patients also receive zoledronate IV over 15 minutes once every 6 months
Arm II delayed therapy Patients receive oral letrozole as in arm I Patients with radiologic evidence of bone loss after 1 year of letrozole therapy receive zoledronate as in arm I
In both arms treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 550 patients 275 per treatment arm will be accrued for this study within 28 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 |
|---|---|---|---|
| CDR0000413877 | REGISTRY | PDQ Physician Data Query | None |