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Circulating Tumor DNA Monitoring in Breast Cancer Undergoing Neoadjuvant Therapy

Circulating Tumor DNA Monitoring in Breast Cancer Undergoing Neoadjuvant Therapy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05649475
Enrollment
100
Registered
2022-12-14
Start date
2021-08-31
Completion date
2025-07-31
Last updated
2023-02-24

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

Conditions

Stage I-III Breast Cancer

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.

Interventions

None listed

Sponsors

GeneCast Biotechnology Co., Ltd.
CollaboratorINDUSTRY
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Miller-Payne grading system3 years
Residual cancer burden (RCB)3 years

Countries

China

Contacts

Primary ContactYunxiang Zhou
yxzhou@zju.edu.cn+8615868131018

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026