Using digital PCR to improve HER2 testing in breast cancer
Implementation of Solid Digital PCR to Support Gold-standard Methods for Evaluation of HER2 Amplification Status: Focus on HER2-low Subtype
IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06813456
This study is testing a new way to check HER2 levels in breast cancer patients to see if it can help doctors make better treatment decisions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 234 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna (other) |
| Locations | 1 site (Bologna, Bologna) |
| Trial ID | NCT06813456 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the effectiveness of solid digital PCR technology and the MammaTyper® diagnostic test in accurately determining HER2 amplification status in breast cancer patients. It includes a retrospective phase to assess the sensitivity and specificity of these techniques, and a prospective phase focusing on HER2-low patients to monitor changes in HER2 expression levels during treatment using liquid biopsy. The goal is to enhance diagnostic accuracy and provide oncologists with better prognostic information to tailor therapies for patients. By correlating HER2 levels with clinical outcomes, the study seeks to refine the classification of breast cancer subtypes and improve treatment strategies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed breast cancer who are classified as HER2-0 or HER2-low and are undergoing systemic and surgical therapy.
Not a fit: Patients with prior neoplasms within the last five years or lacking molecular classification based on prognostic-predictive markers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate HER2 testing and better treatment decisions for breast cancer patients.
How similar studies have performed: Other studies have shown promise in using advanced molecular techniques for cancer diagnostics, but this specific approach is novel in the context of HER2-low breast cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Bologna, Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Bologna, Italy (RECRUITING)
Study contacts
- Principal investigator: Sara Coluccelli, PhD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Sara Coluccelli, PhD
- Email: sara.coluccelli@aosp.bo.it
- Phone: +393290928473
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Breast cancer, HER2, HER2-low, Prognostic-predictive markers, IHC, D-DISH, FISH