Breast CancerNCT06533670
TME Alteration in HER2 Positive Breast Cancer
An observational study of Breast Cancer and HER2-positive Breast Cancer, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Evaluate for changes in the tumor microenvironment before/during neoadjuvant chemotherapy and after treatment in patients diagnosed with HER2-positive advanced breast cancer and receiving neoadjuvant cancer therapy and surgery for curative purposes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, HER2-positive Breast Cancer, Chemotherapy Effect
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Jul 2024to 19 Jul 2026
- How long will I take part?
- 8 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HER2 positive breast cancer patients undergoing curative treatment including neoadjuvant chemotherapy after confirmation of breast cancer without distant metastases
Inclusion criteria i. Adult patients over 18 years of age ii. Patients undergoing curative treatment including neoadjuvant chemotherapy after confirmation of breast cancer without distant metastases iii. Clinical T stage II-IV patients iv. HER2 positive breast cancer patients
Exclusion criteria If you have other comorbidities that, according to the researcher's judgment, may affect the results of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tumor Microenvironment Alteration During Neoadjuvant Chemotherapy in HER2 Positive Breast Cancer Patients
Evaluate for changes in the tumor microenvironment before/during neoadjuvant chemotherapy and after treatment in patients diagnosed with HER2-positive advanced breast cancer and receiving neoadjuvant cancer therapy and surgery for curative purposes.
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor microenvironment alteration
tumor microenvironment changes during neoadjuvant chemotherapy (NAC) for HER2-positive breast cancer.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start19 Jul 2024
- Primary completion19 Jul 2026 (estimated)
- Study completion19 Jul 2026 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 8 Months
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wonshik Han, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533670
- Sponsor's protocol ID
- 2402-110-1514
- Status last verified
- Jan 2026
- First submitted
- 30 Jul 2024
- Last updated
- 28 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor Microenvironment Alteration During Neoadjuvant Chemotherapy in HER2 Positive Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06533670
- Acronym / sponsor ID
- 2402-110-1514
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 19 Jul 2024 (actual)
- Primary completion
- 19 Jul 2026 (estimated)
- Study completion
- 19 Jul 2026 (estimated)
- First posted
- 1 Aug 2024 (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.
Evaluate for changes in the tumor microenvironment before/during neoadjuvant chemotherapy and after treatment in patients diagnosed with HER2-positive advanced breast cancer and receiving neoadjuvant cancer therapy and surgery for curative purposes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HER2 positive breast cancer patients undergoing curative treatment including neoadjuvant chemotherapy after confirmation of breast cancer without distant metastases
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
tumor microenvironment alteration
Time frame: 6 months
tumor microenvironment changes during neoadjuvant chemotherapy (NAC) for HER2-positive breast cancer.
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 28 Jan 2026.
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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?
An observational study of Breast Cancer and HER2-positive 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?
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 28 Jan 2026. 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?
tumor microenvironment alteration (time frame: 6 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 28 Jan 2026.