Clinical trial · Observational
Prognostic Value of Circulating Tumor DNA Dosing in Patients in Neoadjuvant Breast Neoplasia
NCT05050890CI-TRIAL-00054197GIRO_ctDNAunknownClinicalTrials.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 cohort, single-center, prospective study that seeks to analyze the circulating tumor DNA (ctDNA) in patients diagnosed with breast cancer, who will undergo neoadjuvant treatment.
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 Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ctDNA level during neoadjuvant chemotherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Breast cancer
- description
- Breast cancer patients who are currently receiving neoadjuvant therapy
- interventionNames
- Other: ctDNA level during neoadjuvant chemotherapy
Primary outcomes (1)
- measure
- The concentration of circulating DNA(ctDNA)
- timeFrame
- From date of enrollment until the date of end of neoadjuvant treatment, assessed up to 6-7 months
- description
- Circulating tumor DNA (ctDNA) levels will be measured each 15 days until end of neoadjuvant therapy, through peripheral blood collection
Secondary outcomes (1)
- measure
- Change from baseline ctDNA alterations to end of neoadjuvant treatment
- timeFrame
- Up to approximately 7 months starting from Baseline until end of neoadjuvant treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Information to the patient and signed informed consent; * Locally advanced breast cancer that is a candidate for neoadjuvant therapy; * Histological diagnosis of localized invasive breast carcinoma, confirmed by the pathologist, with or without expression of hormone receptors, and/or with the presence of HER-2. Exclusion Criteria: * Metastatic breast cancer (Stage IV); * Additional invasive malignant disease; * Known psychiatric or substance abuse disorders that may interfere with cooperation with study requirements; * Presents any organic condition that makes it impossible to carry out chemotherapy treatment; * Pregnant or lactating women * Received previous treatment for breast cancer.
References
Publications (0)
Data not yet available
No reference posted for this study.