Circulating Tumor DNA Monitoring in Breast Cancer Undergoing Neoadjuvant Therapy

Second Affiliated Hospital, School of Medicine, Zhejiang University1 site in 1 country100 target enrollmentAugust 31, 2021

ConditionsStage I-III Breast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stage I-III Breast Cancer
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Enrollment: 100
Locations: 1
Primary Endpoint: Miller-Payne grading system
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

In the prospective, open, observational study, we aim to evaluate whether circulating tumor DNA (ctDNA) can be the marker of the response to neoadjuvant therapy in stage I-III breast cancer.

Registry

clinicaltrials.gov

Start Date

August 31, 2021

End Date

July 31, 2025

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient is ≥ 18 years-old at the time of consent to participate this trial
•Patients with stage I-III invasive breast cancer
•No prior anti-cancer treatment
•Felt to be a possible candidate for neoadjuvant therapy by their physician

Exclusion Criteria

•Known to have other aggressive malignant tumor in the past 5 years.
•Breast cancer during lactation; Inflammatory breast cancer; Acute inflammatory disease, pregnancy and other conditions may affect the levels of ctDNA and/or peripheral inflammatory indicators.
•There are other concomitant diseases that seriously threaten the patient's safety or affect the patient's completion of the study, such as serious infection, liver disease, cardiovascular disease, kidney disease, respiratory disease or uncontrolled diabetes or dyslipidemia.
•The investigator determines that subjects are not appropriate to participate in the study due to other factors.