NCT03211442

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 7, 2017

Completed
25 days until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

3 years

First QC Date

July 6, 2017

Last Update Submit

February 26, 2024

Conditions

Breast Cancer FemaleAcute Coronary EventsCardiac Complications

Keywords

Breast cancerRadiotherapyCardiac complicationsAcute coronary eventsNTCP model

Outcome Measures

Primary Outcomes (1)

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

    First 10 years after RT treatment

Secondary Outcomes (2)

  • Number of patients with other cardiac complications after completion of RT treatment

    First 10 years after RT treatment

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

    First 10 years after RT treatment

Interventions

RadiotherapyRADIATION

Breast cancer patients treated with radiotherapy

Eligibility Criteria

Age40 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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;
  • Written informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, 9700RB, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 35860581DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2017

First Posted

July 7, 2017

Study Start

August 1, 2017

Primary Completion

August 1, 2020

Study Completion

June 1, 2022

Last Updated

February 28, 2024

Record last verified: 2024-02

Locations

NL(1)