Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072020
Status:
UNKNOWN
Last Update Posted:
2013-08-02
First Post:
2003-11-04
Brief Title:
Chemotherapy andor Hormone Therapy With or Without Zoledronate in Treating Women With Stage II or Stage III Breast Cancer
Sponsor:
University of Sheffield
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Does Adjuvant Zoledronic Acid Reduce Recurrence in Patients With High Risk Localized Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2006-01
Last Known Status:
ACTIVE_NOT_RECRUITING
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 the formation of bone metastases It is not yet known whether chemotherapy andor hormone therapy are more effective with or without zoledronate in preventing cancer recurrence and bone metastases in women with breast cancer
PURPOSE This randomized phase III trial is studying giving chemotherapy andor hormone therapy together with zoledronate to see how well they work compared to chemotherapy andor hormone therapy alone in preventing cancer recurrence and bone metastases in women with stage II or stage III breast cancer
PURPOSE This randomized phase III trial is studying giving chemotherapy andor hormone therapy together with zoledronate to see how well they work compared to chemotherapy andor hormone therapy alone in preventing cancer recurrence and bone metastases in women with stage II or stage III breast cancer
Detailed Description:
OBJECTIVES
Primary
Compare disease-free survival of women with stage II or III breast cancer at high risk of relapse treated with neoadjuvant or adjuvant chemotherapy andor hormonal therapy with vs without zoledronate
Secondary
Compare time to bone metastases as first recurrence in patients treated with these regimens
Compare time to bone metastases per se in patients treated with these regimens
Compare time to distant metastases in patients treated with these regimens
Compare overall survival in patients treated with these regimens
Compare the reduction in skeletal-related events fractures spinal cord compression radiotherapy to the bone surgery to the bone and hypercalcemia before and after the development of bone metastases in patients treated with these regimens
Determine the safety and toxicity of zoledronate in patients treated with these regimens
Correlate prognostic factors such as estrogen-receptor and progesterone-receptor status TNM stage tumor grade HER2neu status and menopausal status with treatment outcome in patients treated with these regimens
Determine more specific prognostic indicators for the development of bone metastases and factors that are able to predict specific benefit from bisphosphonate treatment using proteomics tissue micro-array and other modern techniques in these patients
OUTLINE This is a randomized open-label parallel-group multicenter study Patients are stratified according to participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive neoadjuvant or adjuvant chemotherapy andor hormonal therapy Patients also receive concurrent zoledronate IV over 15 minutes every 3-4 weeks for 6 doses every 3 months for 8 doses and then every 6 months for 5 doses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive neoadjuvant or adjuvant chemotherapy andor hormonal therapy alone
After completion of study treatment patients are followed annually for 5 years
PROJECTED ACCRUAL A total of 3300 patients 1650 per treatment arm will be accrued for this study within 3 years
Primary
Compare disease-free survival of women with stage II or III breast cancer at high risk of relapse treated with neoadjuvant or adjuvant chemotherapy andor hormonal therapy with vs without zoledronate
Secondary
Compare time to bone metastases as first recurrence in patients treated with these regimens
Compare time to bone metastases per se in patients treated with these regimens
Compare time to distant metastases in patients treated with these regimens
Compare overall survival in patients treated with these regimens
Compare the reduction in skeletal-related events fractures spinal cord compression radiotherapy to the bone surgery to the bone and hypercalcemia before and after the development of bone metastases in patients treated with these regimens
Determine the safety and toxicity of zoledronate in patients treated with these regimens
Correlate prognostic factors such as estrogen-receptor and progesterone-receptor status TNM stage tumor grade HER2neu status and menopausal status with treatment outcome in patients treated with these regimens
Determine more specific prognostic indicators for the development of bone metastases and factors that are able to predict specific benefit from bisphosphonate treatment using proteomics tissue micro-array and other modern techniques in these patients
OUTLINE This is a randomized open-label parallel-group multicenter study Patients are stratified according to participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive neoadjuvant or adjuvant chemotherapy andor hormonal therapy Patients also receive concurrent zoledronate IV over 15 minutes every 3-4 weeks for 6 doses every 3 months for 8 doses and then every 6 months for 5 doses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive neoadjuvant or adjuvant chemotherapy andor hormonal therapy alone
After completion of study treatment patients are followed annually for 5 years
PROJECTED ACCRUAL A total of 3300 patients 1650 per treatment arm will be accrued for this study within 3 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BIG-1-04 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000335111 | REGISTRY | None | None |
| EU-20315 | None | None | None |
| ISRCTN79831382 | None | None | None |