Molecular Biomarkers of Response to Radiation Therapy in Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Institute of Oncology Ljubljana
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Adverse events of radiation therapy
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to identify potential genetic and other molecular biomarkers of response to radiation therapy in breast cancer that may help to personalize breast cancer radiation treatment in the future.
Detailed Description
Monocentric prospective clinical study including DCIS patients treated at the Institute of Oncology Ljubljana. Patients treated with adjuvant radiotherapy and without systemic therapy are eligible for the study. Adverse events of radiation treatment will be assessed after radiotherapy and during 5-year follow up and classified according to Common Terminology Criteria for Adverse Events v5.0. Molecular biomarkers will be assessed before radiotherapy, after radiotherapy and during follow up. DNA will be isolated from whole blood samples obtained before radiation treatment. Circulating biomarkers will be isolated from plasma samples before treatment, after treatment and during follow-up. Written informed consent will be obtained from all included patients and the study design was approved by the National Medical Ethics Committee.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Breast cancer patients with DCIS with an indication for adjuvant radiation therapy
Exclusion Criteria
- •Any specific systemic oncological therapy
Outcomes
Primary Outcomes
Adverse events of radiation therapy
Time Frame: 5 years after radiotherapy
We will assess the proportion of patients exhibiting skin and cardiac adverse events after radiotherapy using Common Terminology Criteria for Adverse Events, NYHA class, measurement of cardiac biomarkers and cardiac imaging
Secondary Outcomes
- Disease recurrence(10 years after radiotherapy)
- Changes of circulating biomarkers(5 years after radiotherapy)