An observational study in Breast Cancer and Chemotherapy Induced Systolic Dysfunction, sponsored by RenJi Hospital. Recruiting at 1 site in China. Open to female participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-01.
Sponsored by RenJi Hospital · Observational
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 300 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Inclusion Criteria:
Inclusion Criteria for Control group:
Exclusion Criteria:
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
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
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
Also known as: Echocardiography, EKG
Composite endpoint of cardiac condition
Compose of ejection fraction (%)
Time frame: 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 (%).
Time frame: change between 1 and 6 months after treatment
Exercise tolerance
6 minutes walking test
Time frame: change between 1 and 6 months after treatment
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
RenJi Hospital