Timing of ctDNA Testing in Advanced Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Advanced Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Timing of ctDNA Testing in Advanced Breast Cancer: Impact on Prognosis and Treatment Strategies - A Prospective Observational Study (TIMING)
Overview
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.
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.
Primary outcome measures
- Overall Survival (OS) [Time frame: From diagnosis until death or study completion, up to 3 years]
Secondary outcome measures (4)
- Progression-Free Survival (PFS) [Time frame: 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]
- Correlation of ctDNA level, gene mutations , clonality with treatment response and OS [Time frame: 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences — Beijing
Identifiers
NCT: NCT07681323 · TIMING