An observational study in Advanced Breast Cancer, sponsored by Geneplus-Beijing Co. Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Geneplus-Beijing Co. Ltd. · Observational
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.
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.
Geneplus-Beijing Co. Ltd. is the lead sponsor of 13 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with histologically confirmed advanced breast cancer.
Exclusion Criteria:
Overall Survival (OS)
Time frame: From diagnosis until death or study completion, up to 3 years
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
Plan to share: No
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Geneplus-Beijing Co. Ltd.