Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002528
Status:
COMPLETED
Last Update Posted:
2013-04-04
First Post:
1999-11-01
Brief Title:
Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I or Stage IIA Breast Cancer
Sponsor:
ETOP IBCSG Partners Foundation
Organization:
ETOP IBCSG Partners Foundation
Study Overview
Official Title:
Surgical Therapy With or Without Axillary Node Clearance for Breast Cancer in the Elderly Who Receive Adjuvant Therapy With Tamoxifen
Status:
COMPLETED
Status Verified Date:
2012-07
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:
10-93
Brief Summary:
RATIONALE Removing axillary lymph nodes may be effective in stopping the spread of breast cancer cells It is not yet known if surgery to remove breast cancer is more effective with or without lymph node removal
PURPOSE Randomized phase III trial to compare the effectiveness of breast surgery with or without removal of axillary lymph nodes in treating women who have stage I or stage IIA breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of breast surgery with or without removal of axillary lymph nodes in treating women who have stage I or stage IIA breast cancer
Detailed Description:
OBJECTIVES
Compare local and systemic disease-free survival ipsilateral axillary relapse occurrence of postmastectomy syndrome and overall survival of elderly women with clinically operable stage I or IIA breast cancer who subsequently receive adjuvant tamoxifen after treatment with breast surgery with or without axillary node dissection
Compare the toxicity of these regimens in these patients
Compare the quality of life in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to whether they received prior primary surgery yes vs no and participating center
Arm I Patients undergo mastectomy lumpectomy or quadrantectomy with axillary clearance Patients then receive oral tamoxifen for 5 years Patients may also undergo sentinel node biopsy
Arm II Patients undergo surgery as in arm I without axillary clearance Patients then receive oral tamoxifen for 5 years
Patients in both arms who undergo breast-conserving surgery may receive optional radiotherapy for 5-6 weeks to the remaining breast tissue chest and lung Upon recurrence in the conserved breast patients undergo total mastectomy those in arm II who experience ipsilateral axillary recurrence undergo surgical excision Adjuvant tamoxifen and follow up are continued
Quality of life is assessed
Patients are followed every 3 months for 1 year every 6 months while receiving tamoxifen and then annually thereafter
PROJECTED ACCRUAL A total of 1020 patients will be accrued for this study within approximately 5 years
Compare local and systemic disease-free survival ipsilateral axillary relapse occurrence of postmastectomy syndrome and overall survival of elderly women with clinically operable stage I or IIA breast cancer who subsequently receive adjuvant tamoxifen after treatment with breast surgery with or without axillary node dissection
Compare the toxicity of these regimens in these patients
Compare the quality of life in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to whether they received prior primary surgery yes vs no and participating center
Arm I Patients undergo mastectomy lumpectomy or quadrantectomy with axillary clearance Patients then receive oral tamoxifen for 5 years Patients may also undergo sentinel node biopsy
Arm II Patients undergo surgery as in arm I without axillary clearance Patients then receive oral tamoxifen for 5 years
Patients in both arms who undergo breast-conserving surgery may receive optional radiotherapy for 5-6 weeks to the remaining breast tissue chest and lung Upon recurrence in the conserved breast patients undergo total mastectomy those in arm II who experience ipsilateral axillary recurrence undergo surgical excision Adjuvant tamoxifen and follow up are continued
Quality of life is assessed
Patients are followed every 3 months for 1 year every 6 months while receiving tamoxifen and then annually thereafter
PROJECTED ACCRUAL A total of 1020 patients will be accrued for this study within approximately 5 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 |
|---|---|---|---|
| NCI-F93-0008 | None | None | None |
| IBCSG-10-93 | None | None | None |
| EU-93013 | None | None | None |