Implications of MEDIcal Low Dose RADiation Exposure - BReast Cancer Acute Coronary Events (MEDIRAD-BRACE)

• ClinicalTrials.gov Identifier: NCT03211442
• Recruitment Status: Completed
• First Posted: July 7, 2017
• Last Update Posted: February 28, 2024
• Sponsor: University Medical Center Groningen
• Collaborators: The Netherlands Cancer Institute; Technical University of Munich; Institut de Radioprotection et de Surete Nucleaire
• Information provided by (Responsible Party): University Medical Center Groningen

Tracking Information

• First Submitted Date: July 6, 2017
• First Posted Date: July 7, 2017
• Last Update Posted Date: February 28, 2024
• Actual Study Start Date: August 1, 2017
• Actual Primary Completion Date: August 1, 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 6, 2017): Number of patients with an Acute Coronary Event after completion of RT treatment [ Time Frame: First 10 years after RT treatment ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 6, 2017)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Implications of MEDIcal Low Dose RADiation Exposure - BReast Cancer Acute Coronary Events
• Official Title: Implications of MEDIcal Low Dose RADiation Exposure - BReast Cancer Acute Coronary Events (MEDIRAD-BRACE): A Retrospective Cohort Study
• 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 Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Adult, female patients with stage I-III breast cancer, treated with primary surgery, either by mastectomy of breast conserving surgery, and postoperative RT in the period 2005-2013, and who were aged 40-75 years at the time of RT

Condition

• Breast Cancer Female
• Acute Coronary Events
• Cardiac Complications

Intervention

Radiation: Radiotherapy

Breast cancer patients treated with radiotherapy

• Study Groups/Cohorts: Not Provided
• Publications *: Errahmani MY, Locquet M, Spoor D, Jimenez G, Camilleri J, Bernier MO, Broggio D, Monceau V, Ferrieres J, Thariat J, Boveda S, Kirova Y, Loap P, Langendijk JA, Crijns A, Jacob S. Association Between Cardiac Radiation Exposure and the Risk of Arrhythmia in Breast Cancer Patients Treated With Radiotherapy: A Case-Control Study. Front Oncol. 2022 Jul 4;12:892882. doi: 10.3389/fonc.2022.892882. eCollection 2022.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 6, 2017): 7000
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: June 1, 2022
• Actual Primary Completion Date: August 1, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 40 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT03211442
• Other Study ID Numbers: RT2017-08
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: University Medical Center Groningen
• Original Responsible Party: Johannes A. Langendijk, University Medical Center Groningen, Prof.Dr.
• Current Study Sponsor: University Medical Center Groningen
• Original Study Sponsor: Same as current

Collaborators

• The Netherlands Cancer Institute
• Technical University of Munich
• Institut de Radioprotection et de Surete Nucleaire

• Investigators: Not Provided
• PRS Account: University Medical Center Groningen
• Verification Date: February 2024