Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002934
Status:
TERMINATED
Last Update Posted:
2023-06-22
First Post:
1999-11-01
Brief Title:
Evaluation of Breast Cancer Recurrence Rates Following Surgery in Women With Ductal Carcinoma In Situ
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Local Excision Alone for Selected Patients With DCIS of the Breast
Status:
TERMINATED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was terminated when the accrual goal for the lowintermediate grade stratum was reached The high grade stratum was closed due to slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE The evaluation of breast cancer recurrence rates may improve the ability to plan cancer treatment for patients with breast cancer
PURPOSE Study to evaluate the rate of recurrence of breast cancer in women who have had surgery for ductal carcinoma in situ
PURPOSE Study to evaluate the rate of recurrence of breast cancer in women who have had surgery for ductal carcinoma in situ
Detailed Description:
OBJECTIVES
Evaluate actuarial local in situ and invasive recurrence rates at 5 and 10 years after local excision in women with a favorable ductal carcinoma in situ DCIS prognosis
Evaluate concordance between institutional pathologists and central review pathologists with respect to diagnosis and grading of DCIS
Identify parameters that indicate increased or decreased risk of recurrence in the absence of irradiation
Evaluate patterns of salvage of recurrence and rates of breast conservation
Evaluate actuarial relapse-free overall and cause-specific survival at 5 and 10 years post DCIS excision
OUTLINE This is a registration study stratified by histologic grade high vs low or intermediate and adjuvant tamoxifen therapy yes vs no
Patients receive standard clinical and mammographic follow-up for greater than 10 years If recurrence occurs treatment will be at the discretion of the investigators Patients may receive adjuvant oral tamoxifen daily for 5 years after local excision
A follow up magnification view mammogram must be taken after the last local excision and microcalcification must be negative
Patients are followed every 6 months for the first 10 years and then annually thereafter
PROJECTED ACCRUAL 1000 500 per stratum eligible and evaluable patients will be enrolled at an estimated accrual rate of 250 patients per year
Evaluate actuarial local in situ and invasive recurrence rates at 5 and 10 years after local excision in women with a favorable ductal carcinoma in situ DCIS prognosis
Evaluate concordance between institutional pathologists and central review pathologists with respect to diagnosis and grading of DCIS
Identify parameters that indicate increased or decreased risk of recurrence in the absence of irradiation
Evaluate patterns of salvage of recurrence and rates of breast conservation
Evaluate actuarial relapse-free overall and cause-specific survival at 5 and 10 years post DCIS excision
OUTLINE This is a registration study stratified by histologic grade high vs low or intermediate and adjuvant tamoxifen therapy yes vs no
Patients receive standard clinical and mammographic follow-up for greater than 10 years If recurrence occurs treatment will be at the discretion of the investigators Patients may receive adjuvant oral tamoxifen daily for 5 years after local excision
A follow up magnification view mammogram must be taken after the last local excision and microcalcification must be negative
Patients are followed every 6 months for the first 10 years and then annually thereafter
PROJECTED ACCRUAL 1000 500 per stratum eligible and evaluable patients will be enrolled at an estimated accrual rate of 250 patients per year
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 |
|---|---|---|---|
| E-5194 | US NIH GrantContract | None | httpsreporternihgovquickSearchU10CA021115 |
| U10CA021115 | NIH | None | None |