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

NCT06813456 | Recruiting

• 2 other identifiers: CRANBERRYRC-2024-2790620
• Study Type: observational
• Target: 234
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer

Keywords

Breast cancer; HER2; HER2-low; Prognostic-predictive markers; IHC; D-DISH; FISH; solid digital PCR; liquid biopsy

Outcome Measures

Primary Outcomes (3)

• Breast cancer patients undergone surgical and systemic therapy

  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.

  At baseline

• Early-stage HER2-low breast cancer patients undergoing surgical and systemic therapy

  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

  At baseline

• Metastatic HER2-low patients in treatment with Trastuzumab-Deruxtecan

  Response to Trastuzumab-Deruxtecan therapy to be assessed by tumor markers, radiological investigations and clinical evaluation.

  Every 4 months from the start of therapy,assessed up to 60 months

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population considered for the retrospective phase of the study will consist of women with stage I-III breast cancer, aged 18 years and older, who have accessed the SSD of Breast Surgery and Oncology of IRCCS - Azienda Ospedaliero-Universitaria di Bologna Policlinico di S.Orsola, in the context of the normal care path provided for patients with this pathology (first histopathological diagnosis from 1/1/2022). The population considered for the prospective phase of the study will consist of women with early-stage HER2-0 and HER2-low breast cancer (population 1) or metastatic HER2-low breast cancer (population 2), 18 years of age and older, who will be referred to the SSD of Breast Surgery and Oncology of IRCCS - Azienda Ospedaliero-Universitaria di Bologna Policlinico di S.Orsola.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

FFPE, plasma

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sara Coluccelli, PhD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Coluccelli, PhD

CONTACT

+393290928473; sara.coluccelli@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: February 7, 2025
• Study Start: November 8, 2024
• Primary Completion: November 1, 2025
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 7, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)