Circulating Tumor DNA Monitoring in Breast Cancer Undergoing Neoadjuvant Therapy

Zhejiang University

Status: Enrolling

Conditions: Stage I-III Breast Cancer

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05649475

2021-0532

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

Patients receiving neoadjuvant therapy