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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03211442

Acronym

MEDIRAD-BRACE

Enrollment

7000

Registered

2017-07-07

Start date

2017-08-01

Completion date

2022-06-01

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Events, Breast Cancer Female, Cardiac Complications

Keywords

Breast cancer, Radiotherapy, Cardiac complications, Acute coronary events, NTCP model

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.

Interventions

RADIATIONRadiotherapy

Breast cancer patients treated with radiotherapy

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026