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

University Medical Center Groningen7,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

7,000

Conditions

Breast Cancer Female Acute Coronary Events Cardiac Complications

Interventions

RadiotherapyRADIATION

Breast cancer patients treated with radiotherapy

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

University Medical Center Groningen

Groningen, Netherlands

Outcomes

Primary Outcomes

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

Time frame: First 10 years after RT treatment

Secondary Outcomes

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

Data from ClinicalTrials.gov

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