Using digital PCR to improve HER2 testing in breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.