Timing of ctDNA Testing in Advanced Breast Cancer (TIMING)

July 20, 2026 updated by: Geneplus-Beijing Co. Ltd.

Timing of ctDNA Testing in Advanced Breast Cancer: Impact on Prognosis and Treatment Strategies - A Prospective Observational Study (TIMING)

This multicenter, prospective observational cohort study aims to investigate the impact of circulating tumor DNA (ctDNA) level and key actionable gene mutation status on prognosis and treatment response in patients with advanced breast cancer.

Study Overview

Status

Recruiting

Conditions

Advanced Breast Cancer

Detailed Description

This is a non-interventional, real-world observational study. Patients with histologically confirmed advanced breast cancer, aged ≥18 years, with expected survival >3 months, who consent to ctDNA testing will be enrolled. A total of 400 patients will be recruited from multiple centers in China. Peripheral blood (10 mL) will be collected for ctDNA next-generation sequencing panel testing. Results will be returned to clinicians, who decide on subsequent treatment independently. Baseline data, treatment history, treatment regimens, and efficacy assessments (imaging every 8-12 weeks) will be recorded. Follow-up will continue until death or study end. Primary endpoint: overall survival (OS). Secondary endpoints: progression-free survival (PFS), objective response rate (ORR), correlation of ctDNA level/mutations/clonality with treatment response and OS, and correlation of testing timing/clinical decisions with OS. Statistical analysis will use intention-to-treat (ITT) principle, Kaplan-Meier, Cox regression, and subgroup analyses.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Fei Ma, MD
Phone Number: +8615010127581
Email: drmafei@126.com

Study Locations

China
- - Beijing, China, 100100
    - Recruiting
    - Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    - Principal Investigator:
      
      Fei Ma, MD
    - Contact:
      
      Fei Ma, MD
      
      Phone Number: +8615010127581
      
      Email: drmafei@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Patients with histologically confirmed advanced breast cancer.

Description

Inclusion Criteria:

Histologically confirmed advanced breast cancer
Age ≥18 years
Expected survival >3 months
Willing to undergo ctDNA testing and sign informed consent form

Exclusion Criteria:

The subject has not signed the informed consent form.
Pregnant or breastfeeding women.
Other situations deemed by the investigator as unsuitable for inclusion in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Survival (OS) Time Frame: From diagnosis until death or study completion, up to 3 years	From diagnosis until death or study completion, up to 3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Correlation of ctDNA level, gene mutations , clonality with treatment response and OS Time Frame: From diagnosis to death, up to 3 years	From diagnosis to death, up to 3 years
Correlation of testing timing (first-line vs. later-line) and clinical decision-making with OS Time Frame: From diagnosis to death, up to 3 years	From diagnosis to death, up to 3 years
Progression-Free Survival (PFS) Time Frame: From treatment initiation to progression or death, assessed every 8-12 weeks	From treatment initiation to progression or death, assessed every 8-12 weeks
Objective Response Rate (ORR) Time Frame: From treatment initiation to end of treatment, assessed every 8-12 weeks	From treatment initiation to end of treatment, assessed every 8-12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Geneplus-Beijing Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 8, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

June 26, 2026

First Submitted That Met QC Criteria