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| Name | Class |
|---|---|
| Ruijin Hospital | OTHER |
| Shanghai Fifth People's Hospital | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Control group | The controls were healthy volunteers who have normal electrocardiographic and echocardiographic results and normal CMR findings |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CMR examination | Diagnostic Test | 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 |
| 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 |
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Inclusion Criteria:
Inclusion Criteria for Control group:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meng Jiang, MD | Contact | +86 13788912766 | jiangmeng0919@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Meng Jiang, MD | RenJi Hospital, School of Medicine, Shanghai Jiantong University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital | Recruiting | Shanghai | Shanghai Municipality | 200127 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36844736 | Derived | Chai Y, Jiang M, Wang Y, Liu Q, Lu Q, Tao Z, Wu Q, Yin W, Lu J, Pu J. Protocol for pyrotinib cardiac safety in patients with HER2-positive early or locally advanced breast cancer-The EARLY-MYO-BC study. Front Cardiovasc Med. 2023 Feb 10;10:1021937. doi: 10.3389/fcvm.2023.1021937. eCollection 2023. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D004452 | Echocardiography |
| D004562 | Electrocardiography |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| D017437 |
| Skin and Connective Tissue Diseases |
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D004568 | Electrodiagnosis |