NCT06533670

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
2mo left

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Jul 2024Jul 2026

Study Start

First participant enrolled

July 19, 2024

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2026

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

July 30, 2024

Last Update Submit

January 26, 2026

Conditions

Breast CancerHER2-positive Breast CancerChemotherapy Effect

Outcome Measures

Primary Outcomes (1)

  • tumor microenvironment alteration

    tumor microenvironment changes during neoadjuvant chemotherapy (NAC) for HER2-positive breast cancer.

    6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
8 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 30, 2024

First Posted

August 1, 2024

Study Start

July 19, 2024

Primary Completion (Estimated)

July 19, 2026

Study Completion (Estimated)

July 19, 2026

Last Updated

January 28, 2026

Record last verified: 2026-01

Locations

KR(1)