Detecting early heart injuries in breast cancer patients after treatment

Early Detection of Imaging-derived Subclinical Cardiac Injuries After Radiotherapy and Chemotherapy for Breast Cancer

This study is testing if different heart scans can help find early heart damage in women with breast cancer after they receive surgery, radiation, and chemotherapy.

Quick facts

• Study type: Observational
• Enrollment: 148 (estimated)
• Ages: 40 Years to 70 Years
• Sex: Female
• Sponsor: University Medical Center Groningen (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Groningen)
• Trial ID: NCT03575650 on ClinicalTrials.gov

What this trial studies

This observational study aims to identify early subclinical cardiac injuries (ESCIs) in female breast cancer patients who have undergone surgery followed by adjuvant radiotherapy and chemotherapy. The study will utilize various cardiac imaging techniques, including echocardiography, cardiac MRI, and cardiac CT, to monitor patients before treatment and at 6 and 24 months post-radiotherapy. By analyzing the relationship between radiation doses to cardiac structures and the development of ESCIs, the study seeks to inform preventive strategies for major cardiac events in this patient population.

Who should consider this trial

Good fit: Ideal candidates are female patients aged 40-70 with unilateral breast cancer who are scheduled for adjuvant radiotherapy and chemotherapy.

Not a fit: Patients with metastatic breast cancer or those with a history of significant cardiac conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved monitoring and prevention of cardiac complications in breast cancer patients undergoing radiotherapy and chemotherapy.

How similar studies have performed: While there is limited literature on this specific approach, similar studies have indicated the importance of monitoring cardiac health in patients receiving radiotherapy, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. Female unilateral BC patients
2. Primary breast conserving surgery or mastectomy for stage I-III invasive adenocarcinoma of the breast or ductal carcinoma in situ (DCIS)
3. Age between 40-70 years at time of chemotherapy/radiotherapy
4. WHO performance status 0-1
5. Planned radiotherapy to the breast/chest wall with or without the lymph node areas
6. Radiotherapy based on planning CT-scan, using either 3D CRT, (partial) IMRT or (partial) VMAT/RapidArc with or without deep inspiration breath-hold
7. Adjuvant systemic chemotherapy (before or after radiotherapy)
8. Written informed consent

Exclusion Criteria:

1. Male BC patients
2. M1 disease (metastatic BC)
3. Previous thoracic or mediastinal radiation
4. Neo-adjuvant chemotherapy not allowed
5. Targeted HER2 therapy not allowed
6. Medical history of coronary artery disease and/or myocardial infarction and/or atrial fibrillation
7. Contraindications to injection of iodinated contrast such as allergy or renal failure
8. Pregnancy or lactation
9. Atrial fibrillation detected during electrocardiogram before chemotherapy/radiotherapy
10. Abnormal echocardiography before chemotherapy/radiotherapy defined as: LVEF \<50%, longitudinal strain \<-16%, longitudinal strain rate \<-1%, and/or abnormal wall motion
11. Presence of myocardial infarction detected during cMRI before chemotherapy/radiotherapy
12. cMRI or cCT results before chemotherapy/radiotherapy requiring revascularisation

Where this trial is running

Groningen

• Umcg — Groningen, Netherlands (Recruiting)

Study contacts

• Study coordinator: Anne Crijns, MD, PhD

Conditions Cardiovascular Diseases