CharactHer. ICORG 12-09, V3
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|ClinicalTrials.gov Identifier: NCT01722890|
Recruitment Status : Recruiting
First Posted : November 7, 2012
Last Update Posted : October 12, 2018
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.
The secondary aims of the study are:
- 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;
- To produce data in preparation for further translational studies on HER2-positive breast cancer.
|Condition or disease|
|HER2-positive Breast Cancer TNM Stage II-IV Breast Cancer|
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.
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|
|Estimated Enrollment :||150 participants|
|Official Title:||CharactHer: A Study of the Molecular and Cytogenetic Characteristics of HER2-positive Breast Cancers to Predict Durable Complete Response After Chemotherapy and Trastuzumab|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||January 2019|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01722890
|St. Vincents University Hospital||Recruiting|
|Contact: Contact Person +353 1 221 4000|
|Humanitas Cancer Centre Milan||Not yet recruiting|
|Contact: Contact Person|
|Principal Investigator:||Giuseppe Gullo, Medicine and Surgery||St. Vincent's University Hospital|