CharactHer. ICORG 12-09, V3
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01722890|
Recruitment Status : Active, not recruiting
First Posted : November 7, 2012
Last Update Posted : February 26, 2020
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 :||December 2020|
|Estimated Study Completion Date :||December 2020|
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|
|Humanitas Cancer Centre Milan|
|Principal Investigator:||Giuseppe Gullo, Medicine and Surgery||St. Vincent's University Hospital|