Advanced Breast Cancer
Conditions
Keywords
ctDNA, multigene testing, treatment strategy
Brief summary
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.
Interventions
None listed
Sponsors
Geneplus-Beijing Co. Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | From diagnosis until death or study completion, up to 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) | From treatment initiation to progression or death, assessed every 8-12 weeks |
| Objective Response Rate (ORR) | From treatment initiation to end of treatment, assessed every 8-12 weeks |
| Correlation of ctDNA level, gene mutations , clonality with treatment response and OS | From diagnosis to death, up to 3 years |
| Correlation of testing timing (first-line vs. later-line) and clinical decision-making with OS | From diagnosis to death, up to 3 years |
Countries
China
Contacts
CONTACTFei Ma, MD
Outcome results
None listed