Clinical trial · Observational
ctDNA Monitoring in Early Breast Cancer
Monitoring Circulating Tumor DNA in Patients With Early Stage Breast Cancer
NCT04353557CI-TRIAL-00078938recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Positive ctDNA detection at first post-operative timepoint
- timeFrame
- 1 month post-surgery
- description
- The proportion of patients with ctDNA positivity as assessed by the blood sample taken at first post-operative timepoint
Secondary outcomes (3)
- measure
- Positive ctDNA detection at post-operative timepoints
- timeFrame
- 6/12/18/24/30 months
- description
- The proportion of patients with ctDNA positivity as assessed by the blood sample taken at other post-operative timepoints
- measure
- Association between ctDNA detection and time to recurrence
- timeFrame
- 1 month post-surgery
- description
- Time to recurrence of subgroups with detectable ctDNA and undetectable ctDNA comparison.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients aged 18 to 80 years old 2. Histologically proven primary breast cancer with clinical stage I-III 3. Patients with neoadjuvant therapy, and/or radical surgery/breast conserving surgery, adjuvant chemotherapy and target therapy (Her2+), radiotherapy (if indicated). 4. Expected to achieve R0 resection. 5. Estimated lifetime is more than 3 months. 6. Signed Informed Consent Form 7. Consent to provide research blood samples. Exclusion Criteria: 1. Patients intended to receive adjuvant chemotherapy with Eastern Cooperative Oncology Group (ECOG) performance status 3, 4 or 5. 2. Patients intended to receive postoperative radiotherapy with Eastern Cooperative Oncology Group (ECOG) performance status 5. 3. Prior diagnosis of cancer in the previous 5 years, other than for basal cell carcinoma of the skin or cervical carcinoma in situ. 4. Presence of any systemic illness incompatible with participation in the clinical trial or inability to provide written informed consent.
References
Publications (0)
Data not yet available
No reference posted for this study.