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Circulating Tumor DNA Monitoring in Breast Cancer Undergoing Neoadjuvant Therapy

Recruiting
Conditions
Stage I-III Breast Cancer
Registration Number
NCT05649475
Lead Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
100
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Miller-Payne grading system3 years
Residual cancer burden (RCB)3 years
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

🇨🇳

Hangzhou, China

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