NCT04353557
Recruiting
Not Applicable
Monitoring Circulating Tumor DNA in Patients With Early Stage Breast Cancer
Geneplus-Beijing Co. Ltd.1 site in 1 country200 target enrollmentNovember 29, 2019
ConditionsBreast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Geneplus-Beijing Co. Ltd.
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Positive ctDNA detection at first post-operative timepoint
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
- •Estimated lifetime is more than 3 months.
- •Signed Informed Consent Form
- •Consent to provide research blood samples.
Exclusion Criteria
- •Patients intended to receive adjuvant chemotherapy with Eastern Cooperative Oncology Group (ECOG) performance status 3, 4 or
- •Patients intended to receive postoperative radiotherapy with Eastern Cooperative Oncology Group (ECOG) performance status
- •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.
Outcomes
Primary Outcomes
Positive ctDNA detection at first post-operative timepoint
Time Frame: 1 month post-surgery
The proportion of patients with ctDNA positivity as assessed by the blood sample taken at first post-operative timepoint
Secondary Outcomes
- Positive ctDNA detection at post-operative timepoints(6/12/18/24/30 months)
- Association between ctDNA detection and time to recurrence(6/12/18/24/30 months)
Study Sites (1)
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