Breast CancerNCT04098640
Molecular Profiling in Young (<50 Years of Age) Patients With Metastatic Breast Cancer
A study testing FoundationOne CDx in people with Breast Cancer, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Breast cancer is the most common cancer in women worldwide, especially in developed countries. In developing countries, including South Korea, the incidence and mortality rate of breast cancer is rapidly increasing. Read more about this study
- Who is it for?
- Ages 19 to 50 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- FoundationOne CDx
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Sep 2019to 31 Dec 2025
- Phase
- Interventional
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients between 19 - 50 years of age on the day of signing informed consent.
- Able to provide written informed consent for voluntary participation in the trial.
- With metastatic breast cancer
- Willing to provide biopsies from the primary tumor or lymph nodes at screening to the central laboratory. (with at least 10 unstained slides and 1 H\&E slide)
Who cannot join
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
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
Seoul National University Hospital
Seoul, Seoul, 110-744
About this study
Official title: Molecular Profiling Using FoundationOne CDx in Young (<50 Years of Age) Patients With Metastatic Breast Cancer (ML41263)
Breast cancer is the most common cancer in women worldwide, especially in developed countries. In developing countries, including South Korea, the incidence and mortality rate of breast cancer is rapidly increasing. One of the most important characteristics of breast cancer in South Korea, as well as in other Asian countries, is the younger onset of disease compared to Western.
Medical treatment of breast cancer is evolving rapidly, incorporating immune checkpoint blockades and molecularly targeted agents. However, data and knowledge are still limited in terms of molecular characteristics of Asian breast cancer, compared to that of Western countries, and this remains a major hurdle for drug development in Asian breast cancer patients.
The primary objective of this study is to elucidate the genetic characteristic of young (<50 years of age) Korean patients with metastatic breast cancer using FoundationOne CDx.
Read the detailed description
Secondary Objective(s):
- To evaluate the prognostic and predictive role of tumor mutation burden.
- To reveal the correlation between genetic characteristics and immunohistochemical expression of selected proteins (including DNA damage repair (DDR) molecules and various immune modulating molecules including PD-L1, PD-1, IDO, and OX40).
- Compare molecular characteristics of breast cancer according to age groups (<35 years vs. 35-50 years).
- To offer genomic profiling guided therapy to patients as early as possible (preferably, 1st- or 2nd-line of treatment). In addition, to explore how genomic profiling guided therapy could improve patient outcome as an ad-hoc if sufficient number of patients can be followed up (compared to historic data).
- Conditions
- Breast Cancer
- Being tested
- FoundationOne CDx
- Keywords
- Young patient, Asian
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FoundationOne CDxGenetic
FoundationOne CDx will be performed using archival tumor tissue
| Study group | Role | What they receive |
|---|---|---|
| FMI | Other | FoundationOne CDx will be performed using archival tumor tissue Receives: Genetic: FoundationOne CDx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic characteristic of young (<50 years of age) Korean patients with metastatic breast cancer.
Genetic characteristics will be evaluated using FoundationOne CDx.
Measured: After the end of patient enrollment
Secondary outcomes (4)
Evaluate the prognostic and predictive role of tumor mutation burden
Tumor mutation burden will be analysed using FoundationOne CDx.
Measured: After the end of patient enrollment
Reveal the correlation between genetic characteristics and immunohistochemical expression of selected proteins.
FoundationOne CDx results and immunohistochemical expression will be analysed.
Measured: After the end of patient enrollment
Compare molecular characteristics of breast cancer according to age groups.
Genetic characteristics will be analysed according to age groups.
Measured: After the end of patient enrollment
To offer genomic profiling guided therapy to patients To explore how genomic profiling guided therapy could improve patient outcome as an ad-hoc if sufficient number of patients can be followed up (compared to historic data).
The result of FoundationOne CDx will be used in patient treatment
Measured: After the end of patient enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start23 Sep 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (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 Seoul National University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seock-Ah Im, Seoul National University Hospital
- Investigators
- Seock-Ah Im, MD PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04098640
- Sponsor's protocol ID
- SNUH_FMI
- Status last verified
- Dec 2024
- First submitted
- 19 Sep 2019
- Last updated
- 17 Apr 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 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Profiling Using FoundationOne CDx in Young (<50 Years of Age) Patients With Metastatic Breast Cancer (ML41263)
- ClinicalTrials.gov ID
- NCT04098640
- Acronym / sponsor ID
- SNUH_FMI
- Conditions
- Breast Cancer
- Keywords
- Young patient, Asian
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Sep 2019 (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.
Breast cancer is the most common cancer in women worldwide, especially in developed countries. In developing countries, including South Korea, the incidence and mortality rate of breast cancer is rapidly increasing. One of the most important characteristics of breast cancer in South Korea, as well as in other Asian countries, is the younger onset of disease compared to Western.
Medical treatment of breast cancer is evolving rapidly, incorporating immune checkpoint blockades and molecularly targeted agents. However, data and knowledge are still limited in terms of molecular characteristics of Asian breast cancer, compared to that of Western countries, and this remains a major hurdle for drug development in Asian breast cancer patients.
The primary objective of this study is to elucidate the genetic characteristic of young (<50 years of age) Korean patients with metastatic breast cancer using FoundationOne CDx.
Detailed description
Secondary Objective(s):
- To evaluate the prognostic and predictive role of tumor mutation burden.
- To reveal the correlation between genetic characteristics and immunohistochemical expression of selected proteins (including DNA damage repair (DDR) molecules and various immune modulating molecules including PD-L1, PD-1, IDO, and OX40).
- Compare molecular characteristics of breast cancer according to age groups (<35 years vs. 35-50 years).
- To offer genomic profiling guided therapy to patients as early as possible (preferably, 1st- or 2nd-line of treatment). In addition, to explore how genomic profiling guided therapy could improve patient outcome as an ad-hoc if sufficient number of patients can be followed up (compared to historic data).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FMI | Other | Genetic: FoundationOne CDxFoundationOne CDx will be performed using archival tumor tissue |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients between 19 - 50 years of age on the day of signing informed consent.
- Able to provide written informed consent for voluntary participation in the trial.
- With metastatic breast cancer
- Willing to provide biopsies from the primary tumor or lymph nodes at screening to the central laboratory. (with at least 10 unstained slides and 1 H\&E slide)
Key exclusion criteria (1 listed)
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
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 |
|---|---|---|
| FoundationOne CDxFoundationOne CDx will be performed using archival tumor tissue | Genetic | FMI |
Primary outcome
Genetic characteristic of young (<50 years of age) Korean patients with metastatic breast cancer.
Time frame: After the end of patient enrollment
Genetic characteristics will be evaluated using FoundationOne CDx.
4 secondary outcomes
Evaluate the prognostic and predictive role of tumor mutation burden
Time frame: After the end of patient enrollment
Reveal the correlation between genetic characteristics and immunohistochemical expression of selected proteins.
Time frame: After the end of patient enrollment
Compare molecular characteristics of breast cancer according to age groups.
Time frame: After the end of patient enrollment
To offer genomic profiling guided therapy to patients To explore how genomic profiling guided therapy could improve patient outcome as an ad-hoc if sufficient number of patients can be followed up (compared to historic data).
Time frame: After the end of patient enrollment
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 17 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Seock-Ah Im, MD PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FoundationOne CDx in people with Breast Cancer, run by Seoul National University Hospital 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: enrolling by invitation, as of the sponsor's last update on 17 Apr 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic characteristic of young (<50 years of age) Korean patients with metastatic breast cancer. (time frame: After the end of patient enrollment). 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 17 Apr 2025.