Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00127205
Status:
COMPLETED
Last Update Posted:
2021-07-02
First Post:
2005-08-03
Brief Title:
S0307 Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer
Status:
COMPLETED
Status Verified Date:
2021-06
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 clodronate or ibandronate may delay or prevent bone metastases in patients with nonmetastatic breast cancer It is not yet known whether zoledronate is more effective than clodronate or ibandronate in treating breast cancer
PURPOSE This randomized phase III trial is studying zoledronate to see how well it works compared to clodronate or ibandronate in treating women who have undergone surgery for stage I stage II or stage III breast cancer
PURPOSE This randomized phase III trial is studying zoledronate to see how well it works compared to clodronate or ibandronate in treating women who have undergone surgery for stage I stage II or stage III breast cancer
Detailed Description:
OBJECTIVES
Compare disease-free survival and overall survival of women with resected primary stage I-III adenocarcinoma of the breast treated with adjuvant zoledronate vs clodronate vs ibandronate
Compare the distributions of sites of first disease recurrence in patients treated with these drugs
Compare adverse events in patients treated with these drugs
Correlate parathyroid hormone related protein status and N-telopeptide levels at baseline with disease-free survival and sites of first recurrence in patients treated with these drugs
Investigate whether there is an association between inherited germ-line single nucleotide polymorphisms SNP rs2297480 in farnesyl diphosphate synthase FDPS and the adverse event of acute phase reactions in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 25 years
Arm II Patients receive oral clodronate once daily for 35 months
Arm III Patients receive oral ibandronate once daily for 35 months Treatment in all arms continues in the absence of disease recurrence or unacceptable toxicity
After completion of study treatment patients are followed every 6 months until disease recurrence and then annually for up to 10 years
PROJECTED ACCRUAL A total of 5400 will be accrued for this study
Compare disease-free survival and overall survival of women with resected primary stage I-III adenocarcinoma of the breast treated with adjuvant zoledronate vs clodronate vs ibandronate
Compare the distributions of sites of first disease recurrence in patients treated with these drugs
Compare adverse events in patients treated with these drugs
Correlate parathyroid hormone related protein status and N-telopeptide levels at baseline with disease-free survival and sites of first recurrence in patients treated with these drugs
Investigate whether there is an association between inherited germ-line single nucleotide polymorphisms SNP rs2297480 in farnesyl diphosphate synthase FDPS and the adverse event of acute phase reactions in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 25 years
Arm II Patients receive oral clodronate once daily for 35 months
Arm III Patients receive oral ibandronate once daily for 35 months Treatment in all arms continues in the absence of disease recurrence or unacceptable toxicity
After completion of study treatment patients are followed every 6 months until disease recurrence and then annually for up to 10 years
PROJECTED ACCRUAL A total of 5400 will be accrued for this study
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 |
|---|---|---|---|
| S0307 | OTHER | SWOG | None |