NCT01722890

CharactHer. ICORG 12-09, V3

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 130 (actual)
• Sponsor: Cancer Trials Ireland · Network
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• HER2-positive Breast Cancer
• TNM Stage II-IV Breast Cancer

Timeline

• Start date: 2012-07-01
• Primary completion: 2021-01-27
• Completion: 2021-01-27
• First posted: 2012-11-07
• Last updated: 2025-07-08

Locations

2 sites across 2 countries: Ireland, Italy