Timing of ctDNA Testing in Advanced Breast Cancer

Geneplus-Beijing Co. Ltd.400 enrolled

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.

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

400

Conditions

Advanced Breast Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

Outcomes

Primary Outcomes

Overall Survival (OS)

Time frame: From diagnosis until death or study completion, up to 3 years

Secondary Outcomes

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

Central Contacts

Fei Ma, MD

CONTACT

+8615010127581 drmafei@126.com

Data from ClinicalTrials.gov

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