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RecruitingNCT05907681Updated Jun 29, 2025

Prospective Observational Study on Outcome of High-precision Hypo-fractionated Radiotherapy in Metastatic Breast Cancer (PRECISE-M)

An observational study in Breast Cancer, Metastatic Breast Cancer and Radiation Therapy Complication, sponsored by Samsung Medical Center. Recruiting at 1 site in South Korea. Open to female participants aged 19 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-06-29.

Sponsored by Samsung Medical Center · Observational

From the registry’s dates

  • Started May 2023; still recruiting 3 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
19 Years to 100 Years
Sex
Female
01

Study summary

This study is a prospective observational study on outcomes of high precision hypo-fractionated radiotherapy in breast cancer with distant metastasis.

02

Conditions studied

  • Breast Cancer
  • Metastatic Breast Cancer
  • Radiation Therapy Complication

Browse trials for

03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 400 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 100 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women treated with hypofractionated RT using IMRT, SBRT, or proton therapy for metastatic breast cancer

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • unable to adhere to the study protocol
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Local control rate

    LC after radiation therapy

    Time frame: 1-year

Secondary outcomes

  1. Overall survival rate

    Time frame: 1-year

  2. Disease-free survival

    disease-free survival rate after the time of RT

    Time frame: 1-year

  3. Treatment-related toxicities

    Acute and chronic radiation toxicities according to CTCAE v5.0

    Time frame: 1-year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05907681
Lead sponsor
Samsung Medical Center
Responsible party
Haeyoung Kim (Associate professor, Samsung Medical Center) — Principal investigator
First posted
Jun 18, 2023
Start date
May 11, 2023
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2033 (estimated)
Last update
Jun 29, 2025

Study contacts

Haeyoung Kim
Contact
haeyoung0131.kim@samsung.com
+82-02-3410-2612
won kyung Cho
Contact
wklove.cho@gmail.com
+821087328703
Haeyoung Kim
principal investigator · Samsung Medical Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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