ctDNA Monitoring in Early Breast Cancer

Monitoring Circulating Tumor DNA in Patients With Early Stage Breast Cancer

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04353557

Enrollment

200

Registered

2020-04-20

Start date

2019-11-29

Completion date

2026-12-31

Last updated

2024-07-18

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

Conditions

Breast Cancer

Keywords

ctDNA

Brief summary

This is a observational, single center study, monitoring the circulating tumor DNA (ctDNA) in patients with early breast cancer and assessing the prognostic value and treatment outcome monitoring of ctDNA.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Patients aged 18 to 80 years old 2. Histologically proven primary breast cancer with clinical stage I-III 3. Patients with neoadjuvant therapy, and/or radical surgery/breast conserving surgery, adjuvant chemotherapy and target therapy (Her2+), radiotherapy (if indicated). 4. Expected to achieve R0 resection. 5. Estimated lifetime is more than 3 months. 6. Signed Informed Consent Form 7. Consent to provide research blood samples.

Exclusion criteria

1. Patients intended to receive adjuvant chemotherapy with Eastern Cooperative Oncology Group (ECOG) performance status 3, 4 or 5. 2. Patients intended to receive postoperative radiotherapy with Eastern Cooperative Oncology Group (ECOG) performance status 5. 3. Prior diagnosis of cancer in the previous 5 years, other than for basal cell carcinoma of the skin or cervical carcinoma in situ. 4. Presence of any systemic illness incompatible with participation in the clinical trial or inability to provide written informed consent.

Design outcomes

Primary

Measure	Time frame	Description
Positive ctDNA detection at first post-operative timepoint	1 month post-surgery	The proportion of patients with ctDNA positivity as assessed by the blood sample taken at first post-operative timepoint

Secondary

Measure	Time frame	Description
Positive ctDNA detection at post-operative timepoints	6/12/18/24/30 months	The proportion of patients with ctDNA positivity as assessed by the blood sample taken at other post-operative timepoints
Association between ctDNA detection and time to recurrence	1 month post-surgery	Time to recurrence of subgroups with detectable ctDNA and undetectable ctDNA comparison.

Countries

China

Contacts

Primary ContactYan Xu, M.D.

xy931@163.com(+86)159 2310 0038

Outcome results