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

NCT05893966 | Recruiting

• 1 other identifier: 2022-11-018
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Ipsilateral breast tumor recurrence

  The event for ipsilateral breast tumor recurrence (IBTR) was defined as any breast tumor recurrence in irradiated breast.

  7 years from the start of the postoperative radiation therapy

Secondary Outcomes (4)

• Disease-free survival

  7 years from the start of the postoperative radiation therapy

• Locoregional recurrence

  7 years from the start of the postoperative radiation therapy

• Overall survival

  7 years from the start of the postoperative radiation therapy

• Adverse events

  7 years from the start of the postoperative radiation therapy

Interventions

Whole breast irradiation +/- tumor bed boost RADIATION

Postoperative whole breast irradiation (3D-conformal radiation therapy or IMRT) with or without tumor bed boost (sequential or simultaneous integrated boost)

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any HER2+ invasive breast cancer patient with eligible performance except previous history of radiation therapy to ipsilateral breast

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Haeyoung Kim, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haeyoung Kim, MD, PhD

CONTACT

82-2-3410-2612; haeyoung0131.kim@samsung.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 8, 2023
• Study Start: November 29, 2022
• Primary Completion: November 29, 2025
• Study Completion (Estimated): November 29, 2032
• Last Updated: June 29, 2025

Record last verified: 2025-06

Locations

KR (1)