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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Chemotherapy Induced Systolic Dysfunction
• Intervention / Treatment: Diagnostic test: CMR examination

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Meng Jiang, MD; Phone Number: +86 13788912766; Email: jiangmeng0919@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Recruiting
      • Renji Hospital
      • Contact: Yezi Chai, postgraduate; Phone Number: +8618221507985; Email: cyz960707@126.com
      • Contact: Baohangxing Sun, postgraduate; Phone Number: +8615221478757; Email: bowensun_0719@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

The subjects were prospectively enrolled into 3 cohorts between October 2019 and July 2020. The cohorts were divided as follows: the breast cancer patients with pyrotinib, the breast cancer patients with apatinib and the control group.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group; The controls were healthy volunteers who have normal electrocardiographic and echocardiographic results and normal CMR findings	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; Other Names: Echocardiography; EKG
Patients with Breast Cancer who use pyrotinib; The diagnosis of Breast Cancer was made based on the clinical classification criteria. The subjects were given pyrotinib as having HER2-positive breast cancer with no metastasis.	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; Other Names: Echocardiography; EKG
Patients with Breast Cancer who use apatinib; The diagnosis of Breast Cancer was made based on the clinical classification criteria. The subjects were given apatinib as having HER2-negative breast cancer with no metastasis.	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; Other Names: Echocardiography; EKG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite endpoint of cardiac condition	Compose of ejection fraction (%)	change between 1 and 6 months after treatment
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
Exercise tolerance	6 minutes walking test	change between 1 and 6 months after treatment

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Collaborators: Ruijin Hospital; Shanghai Fifth People's Hospital
• Investigators: Study Chair: Meng Jiang, MD, RenJi Hospital, School of Medicine, Shanghai Jiantong University

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2020
• Primary Completion (Estimated): September 1, 2023
• Study Completion (Estimated): September 1, 2023

Study Registration Dates

• First Submitted: August 7, 2020
• First Submitted That Met QC Criteria: August 11, 2020
• First Posted (Actual): August 12, 2020

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Echocardiography; Cardiac Magnetic Resonance; Chemotherapy-induced Cardiomyopathy; pyrotinib/apatinib
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2020-08-06R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No