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

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05893966
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Anticipated Duration (Months): 120
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Radiation: Whole breast irradiation +/- tumor bed boost

Study Design

• Study Type: Observational
• Anticipated Enrollment: 400 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prospective Cohort for Tumor Bed Boost Radiotherapy in HER2 Positive Breast Cancer
• Actual Study Start Date: Nov 29, 2022
• Anticipated Primary Completion Date: Nov 29, 2025
• Anticipated Study Completion Date: Nov 29, 2032

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

4. Adverse events [7 years from the start of the postoperative radiation therapy]

   Adverse events were evaluated and graded according to CTCAE version 5.0.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of	06351

Sponsors and Collaborators

• Samsung Medical Center

Investigators

• Principal Investigator: Haeyoung Kim, MD, PhD, Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Haeyoung Kim, Associate professor, Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT05893966
• Other Study ID Numbers: 2022-11-018
• First Posted: Jun 8, 2023
• Last Update Posted: Jun 8, 2023
• Last Verified: May 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Jun 8, 2023