Breast CancerBOOST-HER2NCT05893966
Prospective Cohort for Tumor Bed Boost Radiotherapy in HER2 Positive Breast Cancer
An observational study of Breast Cancer, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Whole breast irradiation +/- tumor bed boost
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Nov 2022to 29 Nov 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Any HER2+ invasive breast cancer patient with eligible performance except previous history of radiation therapy to ipsilateral breast
Who may be able to join
- 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
Who cannot join
- Pathological confirmation of ductal carcinoma in situ of the breast
- Previous history of radiation therapy to ipsilateral breast
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, Seoul, 06351
Haeyoung Kim, MD, PhD, 82-2-3410-2612, haeyoung0131.kim@samsung.com
About this study
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
- Being tested
- Whole breast irradiation +/- tumor bed boost
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole breast irradiation +/- tumor bed boostRadiation
Postoperative whole breast irradiation (3D-conformal radiation therapy or IMRT) with or without tumor bed boost (sequential or simultaneous integrated boost)
What is being measured
The primary outcome is the main question the study is designed to answer.
Ipsilateral breast tumor recurrence
The event for ipsilateral breast tumor recurrence (IBTR) was defined as any breast tumor recurrence in irradiated breast.
Measured: 7 years from the start of the postoperative radiation therapy
Secondary outcomes (4)
Disease-free survival
The event for disease-free survival (DFS) was defined as any local, regional, or distant recurrence or breast cancer-related death.
Measured: 7 years from the start of the postoperative radiation therapy
Locoregional recurrence
The event for locoregional recurrence was defined as recurrence in irradiated breast / chest wall or regional lymph node area.
Measured: 7 years from the start of the postoperative radiation therapy
Overall survival
The event for overall survival (OS) was defined as death of any cause.
Measured: 7 years from the start of the postoperative radiation therapy
Adverse events
Adverse events were evaluated and graded according to CTCAE version 5.0.
Measured: 7 years from the start of the postoperative radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start29 Nov 2022
- Primary completion29 Nov 2030 (estimated)
- Study completion29 Nov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haeyoung Kim, Samsung Medical Center
- Investigators
- Haeyoung Kim, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893966
- Sponsor's protocol ID
- 2022-11-018
- Acronym
- BOOST-HER2
- Status last verified
- Aug 2026
- First submitted
- 30 May 2023
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort for Tumor Bed Boost Radiotherapy in HER2 Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT05893966
- Acronym / sponsor ID
- BOOST-HER2 / 2022-11-018
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 29 Nov 2030 (estimated)
- Study completion
- 29 Nov 2032 (estimated)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any HER2+ invasive breast cancer patient with eligible performance except previous history of radiation therapy to ipsilateral breast
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Pathological confirmation of ductal carcinoma in situ of the breast
- Previous history of radiation therapy to ipsilateral breast
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole breast irradiation +/- tumor bed boostPostoperative whole breast irradiation (3D-conformal radiation therapy or IMRT) with or without tumor bed boost (sequential or simultaneous integrated boost) | Radiation | – |
Primary outcome
Ipsilateral breast tumor recurrence
Time frame: 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.
4 secondary outcomes
Disease-free survival
Time frame: 7 years from the start of the postoperative radiation therapy
Locoregional recurrence
Time frame: 7 years from the start of the postoperative radiation therapy
Overall survival
Time frame: 7 years from the start of the postoperative radiation therapy
Adverse events
Time frame: 7 years from the start of the postoperative radiation therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Haeyoung Kim, MD, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haeyoung Kim, MD, PhD (82-2-3410-2612, haeyoung0131.kim@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ipsilateral breast tumor recurrence (time frame: 7 years from the start of the postoperative radiation therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.