Timing of ctDNA Testing in HR+/HER2- Advanced Breast Cancer (TIMING)

June 26, 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 ctDNA level and key actionable gene mutation status on prognosis and treatment response in patients with advanced HR+/HER2- breast cancer.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

This is a non-interventional, real-world observational study. Patients with histologically confirmed advanced HR+/HER2- 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 NGS 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: OS. Secondary endpoints: PFS, 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 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

Study Locations

  • China
      • Beijing, China, 100100
        • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
        • Principal Investigator:
          • Fei Ma, MD
        • Contact:

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

No

Sampling Method

Non-Probability Sample

Study Population

Patients with histologically confirmed advanced HR+/HER2- breast cancer.

Description

Inclusion Criteria:

  • Histologically confirmed advanced breast cancer, molecular subtype HR+/HER2-
  • 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
Progression-Free Survival (PFS)
Time Frame: From enrollment to progression or death, assessed every 8-12 weeks
From enrollment to progression or death, assessed every 8-12 weeks
Objective Response Rate (ORR)
Time Frame: From enrollment to end of treatment, assessed every 8-12 weeks
From enrollment to end of treatment, assessed every 8-12 weeks
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

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)

June 30, 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

June 26, 2026

First Posted (Actual)

July 2, 2026

Study Record Updates

Last Update Posted (Actual)

July 2, 2026

Last Update Submitted That Met QC Criteria

June 26, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TIMING

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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