Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00009945
Status:
COMPLETED
Last Update Posted:
2017-12-13
First Post:
2001-02-02
Brief Title:
Clodronate With or Without Chemotherapy andor Hormonal Therapy in Treating Women With Stage I or Stage II Breast Cancer
Sponsor:
NSABP Foundation Inc
Organization:
NSABP Foundation Inc
Study Overview
Official Title:
A Clinical Trial Comparing Adjuvant Clodronate Therapy vs Placebo in Early-Stage Breast Cancer Patients Receiving Systemic Chemotherapy andor Hormonal Therapy or No Therapy
Status:
COMPLETED
Status Verified Date:
2017-11
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 Clodronate may be effective in preventing the spread of cancer to the bones and other parts of the body It is not yet known whether clodronate is more effective alone or combined with chemotherapy and or hormonal therapy in preventing metastatic breast cancer
PURPOSE Randomized phase III trial to determine the effectiveness of clodronate with or without chemotherapy and or hormonal therapy in preventing metastases in women who have stage I or stage II breast cancer
PURPOSE Randomized phase III trial to determine the effectiveness of clodronate with or without chemotherapy and or hormonal therapy in preventing metastases in women who have stage I or stage II breast cancer
Detailed Description:
OBJECTIVES
Determine whether clodronate administered alone or in addition to adjuvant chemotherapy andor hormonal therapy improves disease-free survival in women with early stage breast cancer
Determine whether clodronate reduces the incidence of skeletal metastases and non-skeletal metastases in these patients
Determine whether clodronate improves overall and relapse-free survival in these patients
Determine whether clodronate reduces the incidence of skeletal morbidity eg skeletal fractures hypercalcemia skeletal pain need for radiotherapy spinal cord compression in these patients
Investigate the relevance of serum markers of bone turnover as a prognostic factor for the development of bone metastasis in these patients
OUTLINE This is a randomized double-blind placebo-controlled study Patients are stratified by age under 50 vs 50 and over number of positive lymph nodes 0 vs 1-3 vs 4 or more and hormone receptor status estrogen receptor ER and progesterone receptor PR negative vs ER andor PR positive Patients are randomized to one of two treatment arms
Patients in both arms commence treatment within 2 weeks of randomization and continue treatment for 3 years in the absence of bone metastasis or unacceptable toxicity Study medication must be continued in the case of documented visceral or soft tissue metastasis or other event without skeletal metastasis
Patients in both arms may also receive adjuvant chemotherapy andor tamoxifen at the discretion of the protocol investigator Patients receiving hormonal therapy begin hormonal therapy within 3-12 weeks after the last dose of chemotherapy and continue for a minimum of 5 years
Patients who have undergone a prior lumpectomy receive adjuvant whole breast radiotherapy Patients who have undergone a prior mastectomy may receive radiotherapy at the investigators discretion
Patients are followed every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 3323 patients will be accrued for this study within 35 years
Determine whether clodronate administered alone or in addition to adjuvant chemotherapy andor hormonal therapy improves disease-free survival in women with early stage breast cancer
Determine whether clodronate reduces the incidence of skeletal metastases and non-skeletal metastases in these patients
Determine whether clodronate improves overall and relapse-free survival in these patients
Determine whether clodronate reduces the incidence of skeletal morbidity eg skeletal fractures hypercalcemia skeletal pain need for radiotherapy spinal cord compression in these patients
Investigate the relevance of serum markers of bone turnover as a prognostic factor for the development of bone metastasis in these patients
OUTLINE This is a randomized double-blind placebo-controlled study Patients are stratified by age under 50 vs 50 and over number of positive lymph nodes 0 vs 1-3 vs 4 or more and hormone receptor status estrogen receptor ER and progesterone receptor PR negative vs ER andor PR positive Patients are randomized to one of two treatment arms
Patients in both arms commence treatment within 2 weeks of randomization and continue treatment for 3 years in the absence of bone metastasis or unacceptable toxicity Study medication must be continued in the case of documented visceral or soft tissue metastasis or other event without skeletal metastasis
Patients in both arms may also receive adjuvant chemotherapy andor tamoxifen at the discretion of the protocol investigator Patients receiving hormonal therapy begin hormonal therapy within 3-12 weeks after the last dose of chemotherapy and continue for a minimum of 5 years
Patients who have undergone a prior lumpectomy receive adjuvant whole breast radiotherapy Patients who have undergone a prior mastectomy may receive radiotherapy at the investigators discretion
Patients are followed every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 3323 patients will be accrued for this study within 35 years
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 |
|---|---|---|---|
| CDR0000068426 | None | None | None |
| SWOG-NSABP-B-34 | None | None | None |
| NCCTG-NSABP-B-34 | None | None | None |