Breast Cancer FemaleMEDIRAD-BRACENCT03211442
Implications of MEDIcal Low Dose RADiation Exposure - BReast Cancer Acute Coronary Events
An observational study of Breast Cancer Female and Acute Coronary Events, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 75 years, women only
- Conditions the study is for
- Breast Cancer Female, Acute Coronary Events, Cardiac Complications
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 7,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Aug 2017to 1 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implications of MEDIcal Low Dose RADiation Exposure - BReast Cancer Acute Coronary Events (MEDIRAD-BRACE): A Retrospective Cohort Study
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.
- Being tested
- Radiotherapy
- Keywords
- Breast cancer, Radiotherapy, Cardiac complications, Acute coronary events, NTCP model
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Breast cancer patients treated with radiotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with an Acute Coronary Event after completion of RT treatment
Measured: First 10 years after RT treatment
Secondary outcomes (2)
Number of patients with other cardiac complications after completion of RT treatment
Measured: First 10 years after RT treatment
Number of patients with radiotherapy-induced late non-cardiac toxicity (e.g. secondary tumors)
Measured: First 10 years after RT treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start1 Aug 2017
- Primary completion1 Aug 2020
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 7,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- The Netherlands Cancer Institute, Technical University of Munich, French Nuclear Safety and Radiation Protection Authority (ASNR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211442
- Sponsor's protocol ID
- RT2017-08
- Acronym
- MEDIRAD-BRACE
- Status last verified
- Feb 2024
- First submitted
- 6 Jul 2017
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 35860581
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implications of MEDIcal Low Dose RADiation Exposure - BReast Cancer Acute Coronary Events (MEDIRAD-BRACE): A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT03211442
- Acronym / sponsor ID
- MEDIRAD-BRACE / RT2017-08
- Keywords
- Breast cancer, Radiotherapy, Cardiac complications, Acute coronary events, NTCP model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,000 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- The Netherlands Cancer Institute, Technical University of Munich, French Nuclear Safety and Radiation Protection Authority (ASNR)
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 7 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapyBreast cancer patients treated with radiotherapy | Radiation | – |
Primary outcome
Number of patients with an Acute Coronary Event after completion of RT treatment
Time frame: First 10 years after RT treatment
2 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Derived from this study: PubMed 35860581Errahmani 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female and Acute Coronary Events, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with an Acute Coronary Event after completion of RT treatment (time frame: First 10 years after RT treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03211442, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.