ctDNA Monitoring in Early Breast Cancer
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorGeneplus-Beijing Co. Ltd.
About this trial
This is a observational, single center study, monitoring the circulating tumor DNA (ctDNA) in patients with early breast cancer and assessing the prognostic value and treatment outcome monitoring of ctDNA.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 to 80 years old
Histologically proven primary breast cancer with clinical stage I-III
Patients with neoadjuvant therapy, and/or radical surgery/breast conserving surgery, adjuvant chemotherapy and target therapy (Her2+), radiotherapy (if indicated).
Expected to achieve R0 resection.
Disqualifiers
Patients intended to receive adjuvant chemotherapy with Eastern Cooperative Oncology Group (ECOG) performance status 3, 4 or 5.
Patients intended to receive postoperative radiotherapy with Eastern Cooperative Oncology Group (ECOG) performance status 5.
Prior diagnosis of cancer in the previous 5 years, other than for basal cell carcinoma of the skin or cervical carcinoma in situ.
Presence of any systemic illness incompatible with participation in the clinical trial or inability to provide written informed consent.
Trial population
Patients with stage I-III breast cancer who planed to receive curative-intent treatment.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Positive ctDNA detection at first post-operative timepoint
The proportion of patients with ctDNA positivity as assessed by the blood sample taken at first post-operative timepoint
Time frame
1 month post-surgerySecondary outcomes
1
Positive ctDNA detection at post-operative timepoints
The proportion of patients with ctDNA positivity as assessed by the blood sample taken at other post-operative timepoints
Time frame
6/12/18/24/30 months2
Association between ctDNA detection and time to recurrence
Time to recurrence of subgroups with detectable ctDNA and undetectable ctDNA comparison.
Time frame
1 month post-surgery3
Association between ctDNA detection and time to recurrence
Time to recurrence of subgroups with detectable ctDNA and undetectable ctDNA
Time frame
6/12/18/24/30 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Geneplus-Beijing Co. Ltd.
Lead sponsor
Army Medical University, China
Collaborator
Source ClinicalTrials.gov