Prospective Cohort for Tumor Bed Boost Radiotherapy in HER2 Positive Breast Cancer

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT05893966
• Lead Sponsor: Samsung Medical Center

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-29
• Study First Submitted: 2023-05-30
• Study First Submitted QC: 2023-05-30
• Study First Posted: 2023-06-08
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-27
• Last Update Posted: 2025-06-29
• Primary Completion: 2025-11-29
• Study Completion: 2032-11-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

• Female patients with age minimum 19
• Pathological confirmation of HER2+ invasive breast cancer
• Eastern Cooperative Oncology Group performance status 0-2
• Informed consent of the participant

Exclusion Criteria

• Pathological confirmation of ductal carcinoma in situ of the breast
• Previous history of radiation therapy to ipsilateral breast

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ipsilateral breast tumor recurrence	7 years from the start of the postoperative radiation therapy	The event for ipsilateral breast tumor recurrence (IBTR) was defined as any breast tumor recurrence in irradiated breast.

Secondary Outcome Measures

Name	Time	Method
Locoregional recurrence	7 years from the start of the postoperative radiation therapy	The event for locoregional recurrence was defined as recurrence in irradiated breast / chest wall or regional lymph node area.
Overall survival	7 years from the start of the postoperative radiation therapy	The event for overall survival (OS) was defined as death of any cause.
Adverse events	7 years from the start of the postoperative radiation therapy	Adverse events were evaluated and graded according to CTCAE version 5.0.
Disease-free survival	7 years from the start of the postoperative radiation therapy	The event for disease-free survival (DFS) was defined as any local, regional, or distant recurrence or breast cancer-related death.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of