ctDNA Monitoring in Early Breast Cancer

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT04353557
• Lead Sponsor: Geneplus-Beijing Co. Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-29
• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2020-04-16
• Study First Posted: 2020-04-20
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-18
• Primary Completion: 2025-06
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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	6/12/18/24/30 months	Time to recurrence of subgroups with detectable ctDNA and undetectable ctDNA

Trial Locations

Locations (1)

Army Medical Center of PLA, China; 🇨🇳 Chongqing, Chongqing, China