Clinical trial · Observational
Circulating Tumor DNA as Marker of Therapeutic Efficacy in Breast Cancer Patients
Early Evaluation of Circulating Tumor DNA as Marker of Therapeutic Efficacy in Breast Cancer Patients During Neoadjuvant Chemotherapy
NCT03881384CI-TRIAL-00038913unknownClinicalTrials.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)
In nonmetastatic local advanced breast cancer patients, we are going to investigate whether circulating tumor DNA (ctDNA) detection can reflect the tumor response to neoadjuvant chemotherapy (NCT) and detect minimal residual disease after surgery.
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ctDNA level during neoadjuant chemotherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- ctDNA level
- description
- ctDNA level during neoadjuant chemotherapy
- interventionNames
- Other: ctDNA level during neoadjuant chemotherapy
Primary outcomes (1)
- measure
- The concentration of circulating DNA(ctDNA)
- timeFrame
- From date of neoadjuvant chemotherapy decided until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
- description
- Take the blood each time before chemtherapy and measure the concentration of ctDNA
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients pre- or post-menopausal must have histologically confirmed early stage/locally advanced invasive breast cancer; * Tumor size ≥ 0.5cm (clinical or radiographic measurements); * Any nodal status allowed; * Age \> 18 years old; * Felt to be a possible candidate for neoadjuvant systemic therapy by their treating physician; * ECOG score\<=2; Exclusion Criteria: * Known metastatic disease; * With serious heart, lung, liver diseases; * Poor cardiac function; * Pregnant; * Patients with other malignant tumor or treated before;
References
Publications (0)
Data not yet available
No reference posted for this study.