Clinical trial NCT03211442: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer Female
Acute Coronary Events
Cardiac Complications
Keywords: Breast cancer
Radiotherapy
Cardiac complications
Acute coronary events
NTCP model
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: The Netherlands Cancer Institute
name: Technical University of Munich
name: Institut de Radioprotection et de Surete Nucleaire
First posted: 2017-07-07
Enrollment: 7000
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


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.

Primary outcomes:
measure: Number of patients with an Acute Coronary Event after completion of RT treatment
timeFrame: First 10 years after RT treatment
Secondary outcomes:
measure: Number of patients with other cardiac complications after completion of RT treatment
timeFrame: First 10 years after RT treatment
measure: Number of patients with radiotherapy-induced late non-cardiac toxicity (e.g. secondary tumors)
timeFrame: First 10 years after RT treatment
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References:
citation: 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.