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

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…

ClinicalTrials.gov IDNCT06813456

PhaseNot Applicable

Enrollment234

SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

Age18 Years

SexFEMALE

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Conditions studied

Breast Cancer

About this study

Primary outcomes

Breast cancer patients undergone surgical and systemic therapy (At baseline)
Early-stage HER2-low breast cancer patients undergoing surgical and systemic therapy (At baseline)
Metastatic HER2-low patients in treatment with Trastuzumab-Deruxtecan (Every 4 months from the start of therapy,assessed up to 60 months)

Eligibility information

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)

Study locations

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Bologna 40138 Italy

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.