Clinical trial · Observational
Implementation of Solid Digital PCR to Support Gold-standard Methods for Evaluation of HER2 Amplification Status: Focus on HER2-low Subtype
- 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 goal of the retrospective phase of this study is to validate the specificity and the sensitivity of two Real-Time quantitative PCR based techniques in order to support the gold-standard approaches used to evaluate the HER2 gene status in breast cancer. Furthemore, HER2-low patients are enrolled in a prospective phase, both in early stage and in case of recurrence, in order to monitorate HER2 expression levels changes under treatments by using liquid biopsy. The first aim is to be able to distinguish responders vs non-responders earlier than the standard monitoring through tumoral markers and medical examination.
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
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Breast cancer patients undergone surgical and systemic therapy
- timeFrame
- At baseline
- description
- Estimation of sensitivity and specificity confidence intervals of MammaTyper and dPCR threshold values in discriminating HER2 positivity on FFPE tissues and comparison with gold-standard approaches.
- measure
- Early-stage HER2-low breast cancer patients undergoing surgical and systemic therapy
- timeFrame
- At baseline
- description
- Sensitivity and specificity of HER2 expression values according to dPCR performed on FFPE tissue and according to dPCR performed on liquid biopsy, compared with the gold-standard approaches
- measure
- Metastatic HER2-low patients in treatment with Trastuzumab-Deruxtecan
- timeFrame
- Every 4 months from the start of therapy,assessed up to 60 months
- description
- Response to Trastuzumab-Deruxtecan therapy to be assessed by tumor markers, radiological investigations and clinical evaluation.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years * Histologic confirmation of breast cancer from 1/1/2022 * Patient treated with systemic and surgical therapy (retrospective phase) * Signed informed consent * HER2-0 and/or HER2-low patient, according to IHC and D-DISH/FISH, treatable with systemic and surgical therapy (prospective phase) Exclusion Criteria: * Lack of molecular classification on the basis of prognostic-predictive markers ER, PR, Ki67 and HER2 (Luminal A, Luminal B HER2-positive, Luminal B HER2- negative, HER2-positive, Triple negative) * Prior neoplasms, other than the neoplasm under investigation, arised within the past 5 years * Missing histological diagnosis of HER2-0 and/or HER2-low breast cancer (prospective phase)
References
Publications (0)
Data not yet available