CharactHer. ICORG 12-09, V3

Terminated

• Conditions: TNM Stage II-IV Breast Cancer; HER2-positive Breast Cancer

• Registration Number: NCT01722890
• Lead Sponsor: Cancer Trials Ireland

Brief Summary

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.

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 Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-10-25
• Study First Submitted QC: 2012-11-05
• Study First Posted: 2012-11-07
• Primary Completion: 2021-01-27
• Study Completion: 2021-01-27
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-04
• Last Update Posted: 2023-04-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 130

Inclusion Criteria

Not provided

Exclusion Criteria

1. Any deviation from the above mentioned Inclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	2 years

Trial Locations

Locations (2)

St. Vincents University Hospital; 🇮🇪 Dublin, Ireland

Humanitas Cancer Centre Milan; 🇮🇹 Milan, Italy