Early Detection of CMP in Patients With Breast Cancer Using Cardiac Magnetic Resonance

Breast Cancer Clinical Trial

Official title:

Early Detection of Chemotherapy-related Cardiomyopathy in Patients With Breast Cancer Using Cardiac Magnetic Resonance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04510532
• Other study ID #: 2020-08-06R
• Status: Recruiting
• Start date: October 30, 2020
• Est. completion date: September 2023

Study information

• Verified date: May 2023
• Source: RenJi Hospital
• Contact: Meng Jiang, MD
• Phone: +86 13788912766
• Email: jiangmeng0919[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Breast cancer is the most common cancers among women worldwide.Although chemotherapy and surgery have greatly improved the survival rate, most types of chemotherapy have been reported to have varying degrees of cardiotoxicity. The investigators will focus on the cardiotoxicity of pyrotinib and apatinib which belong to the new tyrosine kinase inhibitors in respective chemotherapy among more subjects.

Description:

Breast cancer is the most common cancers among women worldwide. Although chemotherapy and surgery have greatly improved the survival rate, most types of chemotherapy have been reported to have varying degrees of cardiotoxicity. We have focused on the field of chemotherapy-related cardiomyopathy. Using the unified magnetic resonance sequences and parameters, effect of chemotherapeutic drugs on the myocardium are studies. Our team's previous pilot study has found that chemotherapy-related cardiomyopathy (CMP) may be predicted within one week after chemotherapy initiation. The specific intervention timing, and the sensitivity and specificity of the early screening indicators are to be explored. At the same time, in patients with human epidermalgrowth factor receptor-2-positive breast cancer, our team observed the change of blood pressure, exercise tolerance and myocardial structure, function and tissue characteristics in patients who used tyrosine kinase inhibitors (pyrotinib and apatinib). This is a supplement to the existing drug knowledge. We are planning to further explore whether it is related to the patient's pre-existing cardiovascular diseases, drug type, dose or dosing. There are no published data addressing the above two research areas. The overall goal is to explore the commonness and specificity of myocardial changes after chemotherapy in breast cancer patients and to predict the development of CMP through multimodality imaging and clinical indices. We aim to propose the CMP time window in respective chemotherapy among more subjects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age between 18-70 years old.

• Invasive breast cancer confirmed by Pathology

• Left ventricular ejection fraction = 50%

• Having not received any prior systemic anti-cancer therapy for advanced disease

• an Eastern Cooperative Oncology Group(ECOG) performance status 0-1

• Providing written informed consent

Inclusion Criteria for Control group:

• Absence of known systemic diseases

• Normal examinations

• Age between 18-70 years old.

• Providing written informed consent

Exclusion Criteria:

• Age <18 years old or >70 years old

• Documented coronary artery disease or prior angiography for coronary artery disease (>50% stenosis).

• Patients with bilateral invasive breast cancers.

• Patients with metastasis of breast cancer confirmed by imaging or pathology

• Patients with standard metallic contraindications to CMR or an estimated glomerular filtration rate < 30 ml/min/1.73 m2.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chemotherapy Induced Systolic Dysfunction

Intervention

Diagnostic Test:
• CMR examination
After recruiting participants and collecting the baseline information, a CMR scan and a post-processed imaging procedure will be carried on .And the follow-up is planned at 1,6 months after chemotherapy in order to detect the cardiac impairment

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
RenJi Hospital	Ruijin Hospital, Shanghai Fifth People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite endpoint of cardiac condition	Compose of ejection fraction (%)	change between 1 and 6 months after treatment
Primary	Composite endpoint of quantitative fibrosis assessment	Compose of percentage of extracellular volume (%) and positive rate of late gadolinium enhancement (%).	change between 1 and 6 months after treatment
Primary	Exercise tolerance	6 minutes walking test	change between 1 and 6 months after treatment