Histologically Confirmed Metastatic or Locally Advanced Breast Cancer With no Radical Topical Treatment AvailablePET-000NCT07173868
FDG PET-CT in Advanced Breast Cancer
An observational study of Histologically Confirmed Metastatic or Locally Advanced Breast Cancer With no Radical Topical Treatment Available and If There is Liver Metastasis, Which the Researcher Believes Will be Difficult to Evaluate the Response Accurately With Bone Metastasis or CT, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study is a prospective cohort study comparing metabolic response evaluation by F-18 FDG PET-CT versus conventional imaging for outcome stratification in patients with advanced breast cancer receiving first-line systemic therapy. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Histologically Confirmed Metastatic or Locally Advanced Breast Cancer With no Radical Topical Treatment Available, If There is Liver Metastasis, Which the Researcher Believes Will be Difficult to Evaluate the Response Accurately With Bone Metastasis or CT
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Jul 2025to 31 Dec 2027
- How long will I take part?
- 12 Months
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Histologically confirmed metastatic or locally advanced breast cancer patients with no radical topical treatment
Who may be able to join
- 19 years of age or older
- histologically confirmed metastatic or locally advanced breast cancer with no radical topical treatment available
- If there is liver metastasis, which the researcher believes will be difficult to evaluate the response accurately with bone metastasis or CT
- May or may not have measurable lesions in accordance with RECIST 1.1 criteria
- Patients who meet the criteria for coverage of F-18 FDG PET-CT tests conducted for the purpose of evaluating treatment response according to the Health Insurance Review and Assessment Service's announcement
- Patients scheduled to start primary systemic therapy for advanced breast cancer (endocrine therapy, targeted therapy, chemotherapy, immunotherapy or their combination therapy)
- Patients willing to undergo continuous response assessments using F-18 FDG PET-CT and CE-CT (± bone scan if clinically necessary) at the time point specified in the study plan (before treatment, 6, 12, 24, 48 weeks after treatment) and willing to pay for the examination accordingly
- ECOG Performance Status 0-2
Who cannot join
- a patient who has previously received systemic treatment for advanced breast cancer
- Taboos for F-18 FDG PET-CT (e.g., uncontrolled diabetes) or intravenous contrast agents for CE-CT (e.g., severe allergies, severe renal dysfunction)
- Pregnancy or lactation
- At the same time, other primary malignancies (except when treatment has been completed for radical purposes) are known
- Other medical conditions that, at the discretion of the researcher, may hinder participation in the study or affect the interpretation of the results
- If you are unable to follow a research procedure or follow-up
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, Gannam-gu, 06351
About this study
Official title: A Prospective Cohort Study Comparing Metabolic Response Evaluation by F-18 FDG PET-CT Versus Conventional Imaging for Outcome Stratification in Patients With Advanced Breast Cancer Receiving First-line Systemic Therapy
This study is a prospective cohort study comparing metabolic response evaluation by F-18 FDG PET-CT versus conventional imaging for outcome stratification in patients with advanced breast cancer receiving first-line systemic therapy.
Read the detailed description
PET-CT, CE-CT ± bone scan are performed before and during treatment (6, 12, 24, 48 weeks) of the first systemic treatment in a total of 100 patients with advanced breast cancer, and some patients analyze ctDNA-based MRD by collecting blood at the same time point. We analyze the relationship between patient-specific responses and PFS, and compare the predictive performance of imaging and molecular indicators.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| F-18 FDG PET-CT in advanced breast cancer | histologically confirmed metastatic or locally advanced breast cancer with no radical topical treatment available If there is liver metastasis, which the researcher believes will be difficult to evaluate the response accurately with bone metastasis or CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follow up the response for 48 weeks after the start of the first systemic treatment
Measured: Within 4 weeks prior to the start of primary systemic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start25 Jul 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Histologically Confirmed Metastatic or Locally Advanced Breast Cancer With no Radical Topical Treatment AvailableStudies 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
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeon Hee Park, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173868
- Sponsor's protocol ID
- 2025-06-039
- Acronym
- PET-000
- Status last verified
- Sep 2025
- First submitted
- 20 Aug 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study Comparing Metabolic Response Evaluation by F-18 FDG PET-CT Versus Conventional Imaging for Outcome Stratification in Patients With Advanced Breast Cancer Receiving First-line Systemic Therapy
- ClinicalTrials.gov ID
- NCT07173868
- Acronym / sponsor ID
- PET-000 / 2025-06-039
- Conditions
- Histologically Confirmed Metastatic or Locally Advanced Breast Cancer With no Radical Topical Treatment Available, If There is Liver Metastasis, Which the Researcher Believes Will be Difficult to Evaluate the Response Accurately With Bone Metastasis or CT
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Sep 2025 (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 cohort study comparing metabolic response evaluation by F-18 FDG PET-CT versus conventional imaging for outcome stratification in patients with advanced breast cancer receiving first-line systemic therapy.
Detailed description
PET-CT, CE-CT ± bone scan are performed before and during treatment (6, 12, 24, 48 weeks) of the first systemic treatment in a total of 100 patients with advanced breast cancer, and some patients analyze ctDNA-based MRD by collecting blood at the same time point. We analyze the relationship between patient-specific responses and PFS, and compare the predictive performance of imaging and molecular indicators.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| F-18 FDG PET-CT in advanced breast cancer | – | –histologically confirmed metastatic or locally advanced breast cancer with no radical topical treatment available If there is liver metastasis, which the researcher believes will be difficult to evaluate the response accurately with bone metastasis or CT |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Histologically confirmed metastatic or locally advanced breast cancer patients with no radical topical treatment
Key inclusion criteria (8 listed)
- 19 years of age or older
- histologically confirmed metastatic or locally advanced breast cancer with no radical topical treatment available
- If there is liver metastasis, which the researcher believes will be difficult to evaluate the response accurately with bone metastasis or CT
- May or may not have measurable lesions in accordance with RECIST 1.1 criteria
- Patients who meet the criteria for coverage of F-18 FDG PET-CT tests conducted for the purpose of evaluating treatment response according to the Health Insurance Review and Assessment Service's announcement
Key exclusion criteria (6 listed)
- a patient who has previously received systemic treatment for advanced breast cancer
- Taboos for F-18 FDG PET-CT (e.g., uncontrolled diabetes) or intravenous contrast agents for CE-CT (e.g., severe allergies, severe renal dysfunction)
- Pregnancy or lactation
- At the same time, other primary malignancies (except when treatment has been completed for radical purposes) are known
- Other medical conditions that, at the discretion of the researcher, may hinder participation in the study or affect the interpretation of the results
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
Follow up the response for 48 weeks after the start of the first systemic treatment
Time frame: Within 4 weeks prior to the start of primary systemic treatment
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 15 Sep 2025.
- Individual participant dataSharing planned: No
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.
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 Histologically Confirmed Metastatic or Locally Advanced Breast Cancer With no Radical Topical Treatment Available and If There is Liver Metastasis, Which the Researcher Believes Will be Difficult to Evaluate the Response Accurately With Bone Metastasis or CT, 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 8 inclusion and 6 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 15 Sep 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 Yeon Hee Park, phD (+82-2-3410-1780, yeonh.park@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Follow up the response for 48 weeks after the start of the first systemic treatment (time frame: Within 4 weeks prior to the start of primary systemic treatment). 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 15 Sep 2025.