TME Alteration in HER2 Positive Breast Cancer | NCT06533670

Studies
TME Alteration in HER2 Positive Breast Cancer

NCT06533670

Sponsor

Seoul National University Hospital

Status

Active, not recruiting

Last Update Posted

Jan 28, 2026Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Breast Cancer
HER2-positive Breast Cancer
Chemotherapy Effect

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 19, 2024Actual

Primary Completion Date

Jul 19, 2026Estimated

Completion Date

Jul 19, 2026Estimated

First Submitted Date

Jul 30, 2024

First Submission Date that Met QC Criteria

Jul 30, 2024

First Posted Date

Aug 1, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2026

Last Update Posted Date

Jan 28, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

8 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
tumor microenvironment alteration	tumor microenvironment changes during neoadjuvant chemotherapy (NAC) for HER2-positive breast cancer.	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

HER2 positive breast cancer patients undergoing curative treatment including neoadjuvant chemotherapy after confirmation of breast cancer without distant metastases

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided