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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

7000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-01

Study Completion Date

2022-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer Female Acute Coronary Events Cardiac Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Radiotherapy

Breast cancer patients treated with radiotherapy

Intervention Type RADIATION

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No