Implementation of Solid Digital PCR to Support Gold-standard Methods for Evaluation of HER2 Amplification Status: Focus on HER2-low Subtype

Plain-language summary

This study looks at using digital PCR to support gold-standard tests for assessing HER2 status in breast cancer, with a focus on the HER2-low subtype. It enrolls people aged 18 and older diagnosed with breast cancer from 2022 onward who are HER2-0 and/or HER2-low. It is a non-phase study and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Recruiting

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Start date

11/8/2024

Estimated completion

12/1/2028

Countries

Italy

Related genes

Locations

• Bologna, Italy

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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)