Triple Negative Breast CancerNCT05955521
Exosome as the Prognostic and Predictive Biomarker in EBC Patients
A study testing exosome and ctDNA evaluation in people with Triple Negative Breast Cancer and HER2-positive Breast Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study is the experimental study for serial ctDNA and exosome evaluation in EBC patients Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Triple Negative Breast Cancer, HER2-positive Breast Cancer
- What is being tested?
- exosome and ctDNA evaluation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2021to 1 Jul 2028
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Early breast cancer
- Planned neoadjuvant chemotherapy
- Triple negative breast cancer or HER2-positive breast cancer
Who cannot join
- Stage IV breast cancer
- Hormone receptor positive breast cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Prognostic and Predictive Biomarker for Locally Advanced Breast Cancer Patients Treated With Neoadjuvant Chemotherapy Using Exosome
This study is the experimental study for serial ctDNA and exosome evaluation in EBC patients
- Being tested
- exosome and ctDNA evaluation
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exosome and ctDNA evaluationProcedure or surgery
Serial exosome and ctDNA evaluation during follow up period between neoadjuvant chemotherapy and surveillance after curative surgery.
| Study group | Role | What they receive |
|---|---|---|
| CtDNA/Exosome evaluation | Experimental | Not described Receives: Procedure: exosome and ctDNA evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic biomarker for EBC
Positive predictive value of ctDNA/Exosome for BC recurrence
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start1 May 2021
- Primary completion1 Jul 2023
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JI-YEON, KIM, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955521
- Sponsor's protocol ID
- EXO_Breast
- Status last verified
- Jul 2023
- First submitted
- 13 Jul 2023
- Last updated
- 21 Jul 2023
- 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 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Prognostic and Predictive Biomarker for Locally Advanced Breast Cancer Patients Treated With Neoadjuvant Chemotherapy Using Exosome
- ClinicalTrials.gov ID
- NCT05955521
- Acronym / sponsor ID
- EXO_Breast
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 21 Jul 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 the experimental study for serial ctDNA and exosome evaluation in EBC patients
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CtDNA/Exosome evaluation | Experimental | Procedure: exosome and ctDNA evaluation |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Early breast cancer
- Planned neoadjuvant chemotherapy
- Triple negative breast cancer or HER2-positive breast cancer
Key exclusion criteria (2 listed)
- Stage IV breast cancer
- Hormone receptor positive breast cancer
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 |
|---|---|---|
| exosome and ctDNA evaluationSerial exosome and ctDNA evaluation during follow up period between neoadjuvant chemotherapy and surveillance after curative surgery. | Procedure or surgery | CtDNA/Exosome evaluation |
Primary outcome
Prognostic biomarker for EBC
Time frame: 60 months
Positive predictive value of ctDNA/Exosome for BC recurrence
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 21 Jul 2023.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exosome and ctDNA evaluation in people with Triple Negative Breast Cancer and HER2-positive 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 3 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: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2023. 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?
Prognostic biomarker for EBC (time frame: 60 months). 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 21 Jul 2023.