Timing of ctDNA Testing in Advanced Breast Cancer
ConditionAdvanced Breast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGeneplus-Beijing Co. Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed advanced breast cancer
Age ≥18 years
Expected survival >3 months
Willing to undergo ctDNA testing and sign informed consent form
Disqualifiers
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.
Trial population
Patients with histologically confirmed advanced breast cancer.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Overall Survival (OS)
Time frame
From diagnosis until death or study completion, up to 3 yearsSecondary outcomes
1
Progression-Free Survival (PFS)
Time frame
From treatment initiation to progression or death, assessed every 8-12 weeks2
Objective Response Rate (ORR)
Time frame
From treatment initiation to end of treatment, assessed every 8-12 weeks3
Correlation of ctDNA level, gene mutations , clonality with treatment response and OS
Time frame
From diagnosis to death, up to 3 years4
Correlation of testing timing (first-line vs. later-line) and clinical decision-making with OS
Time frame
From diagnosis to death, up to 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov