Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002720
Status:
COMPLETED
Last Update Posted:
2013-09-20
First Post:
1999-11-01
Brief Title:
Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I Breast Cancer
Sponsor:
European Institute of Oncology
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
QUADRANTECTOMY PLUS AXILLARY DISSECTION VERSUS QUADRANTECTOMY ALONE IN MAMMOGRAPHIC STAGE T1N0 BREAST CANCER PATIENTS AGED OVER 65 YEARS
Status:
COMPLETED
Status Verified Date:
2000-08
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 Surgery to remove axillary lymph nodes may be an effective treatment for women with breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of therapy with or without axillary lymph node dissection following quadrantectomy in treating older women with stage I breast cancer that is estrogen receptor positive
PURPOSE Randomized phase III trial to compare the effectiveness of therapy with or without axillary lymph node dissection following quadrantectomy in treating older women with stage I breast cancer that is estrogen receptor positive
Detailed Description:
OBJECTIVES
Compare the efficacy of quadrantectomy with or without axillary lymph node dissection followed by tamoxifen in terms of local and distant relapse rates and overall survival of patients with stage I invasive breast cancer
Determine the relationship between biological variables such as hormone receptor status cell proliferation and DNA ploidy and the clinical outcome of the disease in these patients
OUTLINE This is a randomized multicenter study Patients are stratified by center Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo quadrantectomy with dissection of level I and II axillary lymph nodes
Arm II Patients undergo quadrantectomy without axillary lymph node dissection Patients on both arms receive tamoxifen daily for 5 years
Patients are followed every 4 months for 2 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 642 patients will be accrued for this study within 3 years
Compare the efficacy of quadrantectomy with or without axillary lymph node dissection followed by tamoxifen in terms of local and distant relapse rates and overall survival of patients with stage I invasive breast cancer
Determine the relationship between biological variables such as hormone receptor status cell proliferation and DNA ploidy and the clinical outcome of the disease in these patients
OUTLINE This is a randomized multicenter study Patients are stratified by center Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo quadrantectomy with dissection of level I and II axillary lymph nodes
Arm II Patients undergo quadrantectomy without axillary lymph node dissection Patients on both arms receive tamoxifen daily for 5 years
Patients are followed every 4 months for 2 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 642 patients 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 |
|---|---|---|---|
| EU-95020 | None | None | None |
| CNR-9502 | None | None | None |