ctDNA Monitoring in Early Breast Cancer

Breast Cancer Clinical Trial

Official title:

Monitoring Circulating Tumor DNA in Patients With Early Stage Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04353557
• Other study ID #: Geneplus2020BC01
• Status: Recruiting
• Start date: November 29, 2019
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Geneplus-Beijing Co. Ltd.
• Contact: Yan Xu, M.D.
• Phone: (+86)159 2310 0038
• Email: xy931[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
China	Army Medical Center of PLA, China	Chongqing	Chongqing

Sponsors (2)

Lead Sponsor	Collaborator
Geneplus-Beijing Co. Ltd.	Army Medical University, China

Country where clinical trial is conducted

China, 

Outcome

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