Implications of MEDIcal Low Dose RADiation Exposure - BReast Cancer Acute Coronary Events

Breast Cancer Female Clinical Trial

— MEDIRAD-BRACE  

Official title:

Implications of MEDIcal Low Dose RADiation Exposure - BReast Cancer Acute Coronary Events (MEDIRAD-BRACE): A Retrospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03211442
• Other study ID #: RT2017-08
• Status: Completed
• Start date: August 1, 2017
• Est. completion date: June 1, 2022

Study information

• Verified date: February 2024
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

MEDIRAD-BRACE aims to determine the relationship between 3D dose distributions in cardiac structures and the risk of acute coronary events (ACE) and other cardiac complications in breast cancer (BC) patients to develop and externally validate multivariable Normal Tissue Complication Probability (NTCP) models to assess the risk of ACE in individual patients based on cardiac dose metrics in the first 10 years after BC radiotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7000
• Est. completion date: June 1, 2022
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Female breast cancer patients;
• Treated with primary surgery for stage I-III invasive adenocarcinoma of the breast or ductal carcinoma in situ (DCIS);
• Age between 40-75 years at time of start RT;
• WHO performance status 0-1;
• Planned for RT alone to the breast, the chest wall and/or the lymph node areas;
• Start of RT is between 01-01-2015 and 31-12-2013;
• Available planning CT scan and dose distribution;
• Adjuvant systemic treatment, including hormonal therapy or chemotherapy is allowed;
• Medical history of coronary artery disease and/or myocardial infarction is not an exclusion criterion;
• Written informed consent.

Exclusion Criteria:

• Male breast cancer patients;
• Women with metastatic breast cancer (M1 disease);
• Any prior malignancy other than non-melanoma skin cancer;
• Previous thoracic or mediastinal radiation;
• Women treated with neoadjuvant chemotherapy.

Related Conditions & MeSH terms

• Acute Coronary Events
• Breast Cancer Female
• Breast Neoplasms
• Cardiac Complications

Intervention

Radiation:
• Radiotherapy
Breast cancer patients treated with radiotherapy

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (4)

Lead Sponsor	Collaborator
University Medical Center Groningen	Institut de Radioprotection et de Surete Nucleaire, Technical University of Munich, The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with an Acute Coronary Event after completion of RT treatment		First 10 years after RT treatment
Secondary	Number of patients with other cardiac complications after completion of RT treatment		First 10 years after RT treatment
Secondary	Number of patients with radiotherapy-induced late non-cardiac toxicity (e.g. secondary tumors)		First 10 years after RT treatment