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

Breast Cancer Clinical Trial

— BOOST-HER2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05893966
• Other study ID #: 2022-11-018
• Status: Recruiting
• Start date: November 29, 2022
• Est. completion date: November 29, 2032

Study information

• Verified date: May 2023
• Source: Samsung Medical Center
• Contact: Haeyoung Kim, MD, PhD
• Phone: 82-2-3410-2612
• Email: haeyoung0131.kim[@]samsung.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: November 29, 2032
• Est. primary completion date: November 29, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• Whole breast irradiation +/- tumor bed boost
Postoperative whole breast irradiation (3D-conformal radiation therapy or IMRT) with or without tumor bed boost (sequential or simultaneous integrated boost)

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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