Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-25 @ 2:19 PM
Study NCT ID:
NCT05893966
Status:
RECRUITING
Last Update Posted:
2025-06-29
First Post:
2023-05-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Cohort for Tumor Bed Boost Radiotherapy in HER2 Positive Breast Cancer
Sponsor:
Samsung Medical Center
Organization:
Study Overview
Official Title:
Prospective Cohort for Tumor Bed Boost Radiotherapy in HER2 Positive Breast Cancer
Status:
RECRUITING
Status Verified Date:
2025-06
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:
BOOST-HER2
Brief Summary:
The purpose of this study is to analyze treatment outcomes related to tumor bed boost of postoperative radiation therapy in patient with HER2+ breast cancer who underwent breast conserving surgery.
The main questions it aims to answer are:
* 7-year ipsilateral breast tumor recurrence
* 7-year disease-free survival
* 7-year locoregional recurrence
* 7-year overall survival
* Adverse events of radiation therapy
Participants will be assessed by multi-dimensional methods after radiation therapy:
* Assessment for the disease status (disease-free or recurrence) including physical and radiologic examination
* Assessment for the adverse events according to CTCAE version 5.0
The main questions it aims to answer are:
* 7-year ipsilateral breast tumor recurrence
* 7-year disease-free survival
* 7-year locoregional recurrence
* 7-year overall survival
* Adverse events of radiation therapy
Participants will be assessed by multi-dimensional methods after radiation therapy:
* Assessment for the disease status (disease-free or recurrence) including physical and radiologic examination
* Assessment for the adverse events according to CTCAE version 5.0
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: