Clinical trial · Observational
Use of INnovative and Micro-INvasive TEchniques for the Early Identification of Breast Cancer Patients Benefitting From Neo-adjuvant Therapy
NCT05846997CI-TRIAL-00066187INTENTunknownClinicalTrials.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)
The purpose of the study is the identification of novel micro-invasive predictors of pathological complete response (pCR) during neo-adjuvant therapy
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liquid biopsy and imaging | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Identification of novel micro-invasive predictors of pathological complete response (pCR) during neo-adjuvant therapy.
- timeFrame
- from start of therapy until first documented progression, assessed up to 12 months
- description
- 1\. Determine if a PET SUV decrease ≥ 50% after two cycles of therapy respect to the basal value will predict the pCR predict the pCR of breast cancer patients treated with neo-adjuvant therapy;
- measure
- Identification of novel micro-invasive predictors of pathological complete response (pCR) during neo-adjuvant therapy.
- timeFrame
- from start of therapy until first documented progression, assessed up to 12 months
- description
- 2\. Determine if a cfDNA variation ≥ 25% of the basal value after two cycles of therapy will predict the pCR of breast cancer patients treated with neo-adjuvant therapy
Secondary outcomes (6)
- measure
- Determine if the basal number of CTC and/or its variation after two cycle of therapy will predict the pCR of breast cancer patients treated with neo-adjuvant therapy;
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years 2. Histological Diagnosis of Infiltrating Breast Cancer. 3. The presence of measurable mammary lesions; 4. The presence of metabolically active mammary lesions; 5. Performance Status (Eastern Cooperative Oncology Group scale, ECOG) ≤ 1; 6. Compliance with periodic blood withdrawal; 7. Compliance with periodic PET/CT and RMN imaging; 8. Adequate clinical and laboratory test results for undertaking neoadjuvant chemotherapy and surgery; 9. Written informed consent. Exclusion Criteria: 1. The presence of contraindications for the execution of RMN and PET-TC; 2. Presence of metastatic disease; 3. Pre-existing or concurrent tumors, except in situ carcinoma or basophilic carcinoma of the skin; 4. Uncontrolled active infections; 5. Insufficient patient compliance; 6. Absence of signed informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.