CharactHer: A Study of the Molecular and Cytogenetic Characteristics of HER2-positive Breast Cancers to Predict Durable Complete Response After Chemotherapy and Trastuzumab
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Cancer Trials Ireland
- Enrollment
- 130
- Locations
- 2
- Primary Endpoint
- 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.
Study Overview
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:
- 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.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Any deviation from the above mentioned Inclusion criteria
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported