Breast Cancer Long-term Outcomes on Cardiac Functioning: a Longitudinal Study

NCT05851053 | Recruiting DMC

• 1 other identifier: 202100903
• Study Type: observational
• Target: 455
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: In addition to surgery, effective breast cancer (BC) treatment typically requires chemotherapy, radiotherapy, or both. However, it is still unclear whether patients with BC are at increased risk of long-term cardiac dysfunction due to the adverse effects of these therapies. In a cross-sectional study in primary care, a comparison on cardiac dysfunction between 350 BC survivors and 350 age- and general practitioner (GP)- matched controls without cancer was made. In that study, BC survivors were at increased risk of mild systolic cardiac dysfunction (left ventricle ejection fraction (LVEF)\< 54%). By contrast, there was no significant difference in an LVEF \< 50% or in diastolic dysfunction. To date it remains uncertain whether the mild or subclinical dysfunction we observed predicts further cardiac deterioration. Consequently, the translation of these results into guidelines for the daily practice of the GP is unclear. Objective: The aim of the here proposed study is to clarify whether cardiac function in survivors of BC should be monitored by GPs, by assessing whether an unselected population of long-term BC survivors is at increased risk of developing cardiac dysfunction, whether in this group at-risk subgroups exists, and what factors are associated with the highest risk. Study design: A new assessment of cardiac function among women included in the BLOC-I study. This produces a longitudinal matched cohort design consisting of two cohorts in primary care. Study population: Survivors of BC, diagnosed ≥11 years ago who received chemotherapy and/or radiotherapy, and a matched reference population with no history of cancer. All participants participated in the Breast cancer Long-term Outcome of Cardiac function (BLOC-I) study. Main study parameters/endpoints: Left ventricular systolic dysfunction. Systolic cardiac dysfunction is defined as a LVEF \<54/50/45%.

Conditions

Neoplasm, Breast; Heart Failure; Cardiotoxicity; Ventricular Dysfunction

Keywords

Breast cancer; Cardiotoxicity; Heart failure

Outcome Measures

Primary Outcomes (1)

• Left ventricular systolic dysfunction

  Prevalance of systolic cardiac dysfunction defined as a LVEF \<54%

  through study completion (from Ocotober 2022 - December 2024)

Secondary Outcomes (4)

• Clinically used LVEF cut-off points <45% and <50%

  through study completion (from Ocotober 2022 - December 2024)

• Course of cardiac function

  through study completion (from Ocotober 2022 - December 2024)

• Cardiovascular diseases

  through study completion (from Ocotober 2022 - December 2024)

• Symptoms of hearth failure

  through study completion (from Ocotober 2022 - December 2024)

Other Outcomes (7)

• Patient characteristics

  through study completion (from Ocotober 2022 - December 2024)

• Physical activity

  through study completion (from Ocotober 2022 - December 2024)

• Depression

  through study completion (from Ocotober 2022 - December 2024)

Study Arms (2)

Breast cancer survivors

Survivors of BC, diagnosed ≥11 years ago, who received chemotherapy and/or radiotherapy

Diagnostic Test: Echocardiography

Reference population

Age and GP matched reference population without a history of cancer

Diagnostic Test: Echocardiography

Interventions

Echocardiography DIAGNOSTIC_TEST

During echocardiography, the following parameters will be assessed: * Dimensions * Left ventricle function * Right ventricle function * Valves: Aorta valve and pulmonic valve * Other findings such as: frequency, rhythm, quality

Breast cancer survivors; Reference population

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

BC survivors were matched with women of the same age (±1 year) who had the same GP, but who had no history of cancer or cancer treatment (chemotherapy or radiotherapy). A longitudinal matched cohort design consisting of two cohorts in primary care: one with survivors of BC, diagnosed ≥11 years ago who received chemotherapy and/or radiotherapy, and one with a matched reference population with no history of cancer.

You may qualify if:

• Patients who previously took part in de BLOC-I study will be included. These criteria were:
• females diagnosed with stage I-III BC at least five years ago or local or locoregional recurrence of BC at least five years ago
• treatment with chemotherapy and/or radiotherapy.

You may not qualify if:

• Patients unfit to travel to the hospital due to severe mental or physical illness, based on assessment by their GP.
• metastatic disease at the time of BC diagnosis;
• BC treatment after 80 years of age;
• history of treatment for other types of cancer.

Sponsors & Collaborators

• University Medical Center Groningen: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, 9700 AD, Netherlands

RECRUITING

Related Publications (1)

• Boerman LM, Maass SWMC, van der Meer P, Gietema JA, Maduro JH, Hummel YM, Berger MY, de Bock GH, Berendsen AJ. Long-term outcome of cardiac function in a population-based cohort of breast cancer survivors: A cross-sectional study. Eur J Cancer. 2017 Aug;81:56-65. doi: 10.1016/j.ejca.2017.05.013. Epub 2017 Jun 8.

  PMID: 28601706 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Heart Failure; Cardiotoxicity; Ventricular Dysfunction

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Central Study Contacts

Daan Brandenbarg, PhD

CONTACT

0031628475305; d.brandenbarg@umcg.nl

Laurine T van der Wal, MSc

CONTACT

0031503616154; l.t.van.der.wal@umcg.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: May 9, 2023
• Study Start: September 1, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

NL (1)