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Exosome as the Prognostic and Predictive Biomarker in EBC Patients

Development of a Prognostic and Predictive Biomarker for Locally Advanced Breast Cancer Patients Treated With Neoadjuvant Chemotherapy Using Exosome

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05955521
Enrollment
200
Registered
2023-07-21
Start date
2021-05-01
Completion date
2028-07-01
Last updated
2023-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HER2-positive Breast Cancer, Triple Negative Breast Cancer

Brief summary

This study is the experimental study for serial ctDNA and exosome evaluation in EBC patients

Interventions

PROCEDUREexosome and ctDNA evaluation

Serial exosome and ctDNA evaluation during follow up period between neoadjuvant chemotherapy and surveillance after curative surgery.

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

Inclusion criteria

* Early breast cancer * Planned neoadjuvant chemotherapy * Triple negative breast cancer or HER2-positive breast cancer

Exclusion criteria

* Stage IV breast cancer * Hormone receptor positive breast cancer

Design outcomes

Primary

MeasureTime frameDescription
Prognostic biomarker for EBC60 monthsPositive predictive value of ctDNA/Exosome for BC recurrence

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026