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

Completed

• Conditions: Breast Cancer Female; Cardiac Complications; Acute Coronary Events

• Registration Number: NCT03211442
• Lead Sponsor: University Medical Center Groningen

Brief 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2017-07-06
• Study First Submitted QC: 2017-07-06
• Study First Posted: 2017-07-07
• Study Start: 2017-08-01
• Primary Completion: 2020-08-01
• Study Completion: 2022-06-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7000

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.

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with an Acute Coronary Event after completion of RT treatment	First 10 years after RT treatment

Secondary Outcome Measures

Name	Time	Method
Number of patients with other cardiac complications after completion of RT treatment	First 10 years after RT treatment
Number of patients with radiotherapy-induced late non-cardiac toxicity (e.g. secondary tumors)	First 10 years after RT treatment

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands