Clinical trial NCT04510532: Early Detection of CMP in Patients With Breast Cancer Using Cardiac Magnetic Resonance
Official title: Early Detection of Chemotherapy-related Cardiomyopathy in Patients With Breast Cancer Using Cardiac Magnetic Resonance
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Chemotherapy Induced Systolic Dysfunction
Keywords: Chemotherapy-induced Cardiomyopathy
pyrotinib/apatinib
Cardiac Magnetic Resonance
Echocardiography
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Ruijin Hospital
name: Shanghai Fifth People's Hospital
First posted: 2020-08-12
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Composite endpoint of cardiac condition
timeFrame: change between 1 and 6 months after treatment
measure: Composite endpoint of quantitative fibrosis assessment
timeFrame: change between 1 and 6 months after treatment
measure: Exercise tolerance
timeFrame: change between 1 and 6 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
affiliation: RenJi Hospital, School of Medicine, Shanghai Jiantong University
name: Meng Jiang, MD
role: STUDY_CHAIR
References: