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Completed

NCT Number: NCT03211442

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

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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Key information

Conditions

Breast Cancer Female Acute Coronary Events Breast Diseases Breast Neoplasms Cardiac Complications Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

40 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, 9700RB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radiotherapy

Radiation

Breast cancer patients treated with radiotherapy

Primary outcomes

  1. Number of patients with an Acute Coronary Event after completion of RT treatment

    Time frame: First 10 years after RT treatment

Secondary outcomes

  1. Number of patients with other cardiac complications after completion of RT treatment

    Time frame: First 10 years after RT treatment

  2. Number of patients with radiotherapy-induced late non-cardiac toxicity (e.g. secondary tumors)

    Time frame: First 10 years after RT treatment

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • French Nuclear Safety and Radiation Protection Authority (ASNR)
  • Technical University of Munich
  • The Netherlands Cancer Institute

Registry information

Official study title

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

Acronym: MEDIRAD-BRACE

Important dates

Study start
2017
Primary completion
2020
Study completion
2022
First posted
Jul 7, 2017
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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