Breast CancerNCT05907681
Prospective Observational Study on Outcome of High-precision Hypo-fractionated Radiotherapy in Metastatic Breast Cancer (PRECISE-M)
An observational study of Breast Cancer and Metastatic Breast Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study is a prospective observational study on outcomes of high precision hypo-fractionated radiotherapy in breast cancer with distant metastasis. Read more about this study
- Who is it for?
- Ages 19 to 100 years, women only
- Conditions the study is for
- Breast Cancer, Metastatic Breast Cancer, Radiation Therapy Complication
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 May 2023to 31 Dec 2033
- How long will I take part?
- 5 Years
- 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 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women treated with hypofractionated RT using IMRT, SBRT, or proton therapy for metastatic breast cancer
Who may be able to join
- histologically confirmed breast cancer
- presence of distant metastasis
- radiation therapy using IMRT, SBRT, or proton therapy is done or planned
- Able and willing to comply with the study protocol
Who cannot join
- unable to adhere to the study protocol
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
Won Park, wonro.park@samsung.com
About this study
This study is a prospective observational study on outcomes of high precision hypo-fractionated radiotherapy in breast cancer with distant metastasis.
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Local control rate
LC after radiation therapy
Measured: 1-year
Secondary outcomes (3)
Overall survival rate
Measured: 1-year
Disease-free survival
disease-free survival rate after the time of RT
Measured: 1-year
Treatment-related toxicities
Acute and chronic radiation toxicities according to CTCAE v5.0
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start11 May 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2033 (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)
- Target duration
- 5 Years
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, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907681
- Sponsor's protocol ID
- 2023-04-032-003
- Status last verified
- Jun 2025
- First submitted
- 8 Jun 2023
- Last updated
- 29 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study on Outcome of High-precision Hypo-fractionated Radiotherapy in Metastatic Breast Cancer (PRECISE-M)
- ClinicalTrials.gov ID
- NCT05907681
- Acronym / sponsor ID
- 2023-04-032-003
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 11 May 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 18 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.
This study is a prospective observational study on outcomes of high precision hypo-fractionated radiotherapy in breast cancer with distant metastasis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 19 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women treated with hypofractionated RT using IMRT, SBRT, or proton therapy for metastatic breast cancer
Key inclusion criteria (4 listed)
- histologically confirmed breast cancer
- presence of distant metastasis
- radiation therapy using IMRT, SBRT, or proton therapy is done or planned
- Able and willing to comply with the study protocol
Key exclusion criteria (1 listed)
- unable to adhere to the study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Local control rate
Time frame: 1-year
LC after radiation therapy
3 secondary outcomes
Overall survival rate
Time frame: 1-year
Disease-free survival
Time frame: 1-year
Treatment-related toxicities
Time frame: 1-year
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 29 Jun 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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 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 and Metastatic 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 1 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 29 Jun 2025. 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 (+82-02-3410-2612, haeyoung0131.kim@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local control rate (time frame: 1-year). 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 29 Jun 2025.