Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 4:15 PM
Study NCT ID:
NCT05371860
Status:
WITHDRAWN
Last Update Posted:
2023-09-22
First Post:
2022-04-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiation Omission in Patients With HER2 Overexpressing Tumors With Pathologic Complete Response
Sponsor:
Armando Giuliano
Organization:
Study Overview
Official Title:
Radiation Omission in Patients With HER2 Overexpressing Tumors With Pathologic
Status:
WITHDRAWN
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI voluntarily closed the study. Will be reopened as a national cooperative group trial.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the feasibility, based on recruitment rate over a 3-year period, of enrolling patients for the omission of post-operative breast radiation following breast conserving surgery and sentinel node biopsy or axillary lymph node dissection in women with HER2+ breast cancer who achieve pathologic complete response.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: