CharactHer. ICORG 12-09, V3

July 4, 2025 updated by: Cancer Trials Ireland

CharactHer: A Study of the Molecular and Cytogenetic Characteristics of HER2-positive Breast Cancers to Predict Durable Complete Response After Chemotherapy and Trastuzumab

Primary Objective:

The primary aim of the study is:

1.To identify and validate a panel of molecular and cytogenetic biomarkers able to predict Durable Complete Response (DCR) after chemotherapy and trastuzumab in patients with HER2-positive locally advanced or metastatic breast cancer.

Secondary Objective:

The secondary aims of the study are:

  1. To perform a comprehensive exploration of the molecular and cytogenetic characteristics of DCR patients to identify any possible correlation between the tumour's biological and cytogenetic characteristics and the degree of clinical response to trastuzumab;
  2. To produce data in preparation for further translational studies on HER2-positive breast cancer.

Study Overview

Status

Terminated

Conditions

Detailed Description

Type of Study: Translational

This is a pilot retrospective laboratory-based cohort study.

Eligible patients will be identified at each one of the participating institutions by a systematic cross-matching of the datasets of Medical Oncology, Pathology and Pharmacy Departments.

Patient Population:

Cohort 1: TNM stage II-IV breast cancer patients with highly trastuzumab-sensitive tumours.

Cohort 2: (Control group) TNM stage II-IV breast cancer patients with trastuzumab-refractory disease.

Study Type

Observational

Enrollment (Actual)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland
        • St. Vincents University Hospital
  • Italy
      • Milan, Italy
        • Humanitas Cancer Centre Milan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Study population will consist of two separate cohorts of patients with HER2-positive breast cancer that will be analysed based on their responsiveness to trastuzumab-containing chemotherapy. Cohort 1 will include patients with TNM stage II-IV breast cancer with highly trastuzumab-sensitive tumours. Results of laboratory analyses from Cohort 1 will be matched with those from Cohort 2 (Control group) that includes patients at the same TNM clinical stages but with trastuzumab-refractory disease.

Description

Inclusion criteria for Cohort 1:

  1. Histologically proven AJCC TNM stage II-IV invasive breast cancer
  2. HER2-positivity defined as score 3+ on IHC and/or with HER2/neu amplification on FISH test (HER2/CEP17 ratio >2.0 on PathVysion test)
  3. Evidence of complete response (CR) according to RECIST 1.1 criteria lasting for at least 36 months (for stage IV patients only) following a first-line chemotherapy and trastuzumab
  4. Pathological Complete Response (pCR) following a neo-adjuvant chemotherapy (CT) and trastuzumab (for stage II-III patients only). pCR is defined as no evidence of residual invasive carcinoma in the breast (ductal carcinoma in situ (DCIS) is allowed) AND in all the examined lymph nodes (micro-metastases and isolated tumour cells are not allowed).
  5. At least one FFPE archived tissue sample from the primary tumour and/or a metastatic site(s) available for laboratory analyses
  6. Adequate follow up information

Inclusion criteria for Cohort 2:

  1. Histologically proven AJCC TNM stage II-IV invasive breast cancer
  2. HER2-positivity defined as score 3+ on IHC and/or with HER2/neu amplification on FISH test (HER2/CEP17 ratio>2.0 on PathVysion test)
  3. Progression of disease according to RECIST 1.1 while receiving trastuzumab (in association with chemotherapy or as single agent as maintenance therapy) or within 6 months from last dose of trastuzumab (for stage IV patients only)
  4. Residual invasive tumour in the breast larger than 2cm and /or at least one micro- or macro-metastasis in the axillary lymph nodes following pre-operative trastuzumab-containing chemotherapy (for stage II-III patients only)
  5. At least one FFPE archived tissue sample from the primary tumour and/or a metastatic site(s) available for laboratory analyses
  6. Adequate follow up information

Exclusion Criteria:

1. Any deviation from the above mentioned Inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort 1
TNM stage II-IV breast cancer patients with highly trastuzumab-sensitive tumours.
Cohort 2(Control Group)
TNM stage II-IV breast cancer patients with trastuzumab-refractory disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Panel of molecular and cytogenetic biomarkers able to predict Durable Complete Response (DCR) after chemotherapy and trastuzumab in patients with HER2-positive locally advanced or metastatic breast cancer.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Trials Ireland

Investigators

  • Principal Investigator: Giuseppe Gullo, Medicine and Surgery, St Vincent's University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2012

Primary Completion (Actual)

January 27, 2021

Study Completion (Actual)

January 27, 2021

Study Registration Dates

First Submitted

October 25, 2012

First Submitted That Met QC Criteria

November 5, 2012

First Posted (Estimated)

November 7, 2012

Study Record Updates

Last Update Posted (Actual)

July 8, 2025

Last Update Submitted That Met QC Criteria

July 4, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICORG 12-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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