Protocol for pyrotinib cardiac safety in patients with HER2-positive early or locally advanced breast cancer–The EARLY-MYO-BC study
Background and aimCardiotoxicity has become the most common cause of non-cancer death among breast cancer patients. Pyrotinib, a tyrosine kinase inhibitor targeting HER2, has been successfully used to treat breast cancer patients but has also resulted in less well-understood cardiotoxicity. This pro...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2023-02-01
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| Series: | Frontiers in Cardiovascular Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fcvm.2023.1021937/full |
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| author | Yezi Chai Meng Jiang Yaohui Wang Qiming Liu Qifan Lu Zhengyu Tao Qizhen Wu Wenjin Yin Jinsong Lu Jun Pu |
| author_facet | Yezi Chai Meng Jiang Yaohui Wang Qiming Liu Qifan Lu Zhengyu Tao Qizhen Wu Wenjin Yin Jinsong Lu Jun Pu |
| author_sort | Yezi Chai |
| collection | DOAJ |
| description | Background and aimCardiotoxicity has become the most common cause of non-cancer death among breast cancer patients. Pyrotinib, a tyrosine kinase inhibitor targeting HER2, has been successfully used to treat breast cancer patients but has also resulted in less well-understood cardiotoxicity. This prospective, controlled, open-label, observational trial was designed to characterize pyrotinib’s cardiac impacts in the neoadjuvant setting for patients with HER2-positive early or locally advanced breast cancer.Patients and methodsThe EARLY-MYO-BC study will prospectively enroll HER2-positive breast cancer patients who are scheduled to receive four cycles of neoadjuvant therapy with pyrotinib or pertuzumab added to trastuzumab before radical breast cancer surgery. Patients will undergo comprehensive cardiac assessment before and after neoadjuvant therapy, including laboratory measures, electrocardiography, transthoracic echocardiography, cardiopulmonary exercise testing (CPET), and cardiac magnetic resonance (CMR). To test the non-inferiority of pyrotinib plus trastuzumab therapy to pertuzumab plus trastuzumab therapy in terms of cardiac safety, the primary endpoint will be assessed by the relative change in global longitudinal strain from baseline to completion of neoadjuvant therapy by echocardiography. The secondary endpoints include myocardial diffuse fibrosis (by T1-derived extracellular volume), myocardial edema (by T2 mapping), cardiac volumetric assessment by CMR, diastolic function (by left ventricular volume, left atrial volume, E/A, and E/E’) by echocardiography, and exercise capacity by CPET.DiscussionThis study will comprehensively assess the impacts of pyrotinib on myocardial structural, function, and tissue characteristics, and, furthermore, will determine whether pyrotinib plus trastuzumab is a reasonable dual HER2 blockade regimen with regard to cardiac safety. Results may provide information in selecting an appropriate anti-HER2 treatment for HER2-positive breast cancer.Clinical trial registrationhttps://clinicaltrials.gov/, identifier NCT04510532 |
| first_indexed | 2024-04-10T16:04:47Z |
| format | Article |
| id | doaj.art-63a72390720b4a4893220bd65b307195 |
| institution | Directory Open Access Journal |
| issn | 2297-055X |
| language | English |
| last_indexed | 2024-04-10T16:04:47Z |
| publishDate | 2023-02-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Cardiovascular Medicine |
| spelling | doaj.art-63a72390720b4a4893220bd65b3071952023-02-10T06:04:28ZengFrontiers Media S.A.Frontiers in Cardiovascular Medicine2297-055X2023-02-011010.3389/fcvm.2023.10219371021937Protocol for pyrotinib cardiac safety in patients with HER2-positive early or locally advanced breast cancer–The EARLY-MYO-BC studyYezi Chai0Meng Jiang1Yaohui Wang2Qiming Liu3Qifan Lu4Zhengyu Tao5Qizhen Wu6Wenjin Yin7Jinsong Lu8Jun Pu9Division of Cardiology, State Key Laboratory for Oncogenes and Related Genes, Key Laboratory of Coronary Heart Disease, School of Medicine, Renji Hospital, Shanghai Jiao Tong University, Shanghai, ChinaDivision of Cardiology, State Key Laboratory for Oncogenes and Related Genes, Key Laboratory of Coronary Heart Disease, School of Medicine, Renji Hospital, Shanghai Jiao Tong University, Shanghai, ChinaDepartment of Breast Surgery, School of Medicine, Renji Hospital, Shanghai Jiao Tong University, Shanghai, ChinaDivision of Cardiology, State Key Laboratory for Oncogenes and Related Genes, Key Laboratory of Coronary Heart Disease, School of Medicine, Renji Hospital, Shanghai Jiao Tong University, Shanghai, ChinaDivision of Cardiology, State Key Laboratory for Oncogenes and Related Genes, Key Laboratory of Coronary Heart Disease, School of Medicine, Renji Hospital, Shanghai Jiao Tong University, Shanghai, ChinaDivision of Cardiology, State Key Laboratory for Oncogenes and Related Genes, Key Laboratory of Coronary Heart Disease, School of Medicine, Renji Hospital, Shanghai Jiao Tong University, Shanghai, ChinaDivision of Cardiology, State Key Laboratory for Oncogenes and Related Genes, Key Laboratory of Coronary Heart Disease, School of Medicine, Renji Hospital, Shanghai Jiao Tong University, Shanghai, ChinaDepartment of Breast Surgery, School of Medicine, Renji Hospital, Shanghai Jiao Tong University, Shanghai, ChinaDepartment of Breast Surgery, School of Medicine, Renji Hospital, Shanghai Jiao Tong University, Shanghai, ChinaDivision of Cardiology, State Key Laboratory for Oncogenes and Related Genes, Key Laboratory of Coronary Heart Disease, School of Medicine, Renji Hospital, Shanghai Jiao Tong University, Shanghai, ChinaBackground and aimCardiotoxicity has become the most common cause of non-cancer death among breast cancer patients. Pyrotinib, a tyrosine kinase inhibitor targeting HER2, has been successfully used to treat breast cancer patients but has also resulted in less well-understood cardiotoxicity. This prospective, controlled, open-label, observational trial was designed to characterize pyrotinib’s cardiac impacts in the neoadjuvant setting for patients with HER2-positive early or locally advanced breast cancer.Patients and methodsThe EARLY-MYO-BC study will prospectively enroll HER2-positive breast cancer patients who are scheduled to receive four cycles of neoadjuvant therapy with pyrotinib or pertuzumab added to trastuzumab before radical breast cancer surgery. Patients will undergo comprehensive cardiac assessment before and after neoadjuvant therapy, including laboratory measures, electrocardiography, transthoracic echocardiography, cardiopulmonary exercise testing (CPET), and cardiac magnetic resonance (CMR). To test the non-inferiority of pyrotinib plus trastuzumab therapy to pertuzumab plus trastuzumab therapy in terms of cardiac safety, the primary endpoint will be assessed by the relative change in global longitudinal strain from baseline to completion of neoadjuvant therapy by echocardiography. The secondary endpoints include myocardial diffuse fibrosis (by T1-derived extracellular volume), myocardial edema (by T2 mapping), cardiac volumetric assessment by CMR, diastolic function (by left ventricular volume, left atrial volume, E/A, and E/E’) by echocardiography, and exercise capacity by CPET.DiscussionThis study will comprehensively assess the impacts of pyrotinib on myocardial structural, function, and tissue characteristics, and, furthermore, will determine whether pyrotinib plus trastuzumab is a reasonable dual HER2 blockade regimen with regard to cardiac safety. Results may provide information in selecting an appropriate anti-HER2 treatment for HER2-positive breast cancer.Clinical trial registrationhttps://clinicaltrials.gov/, identifier NCT04510532https://www.frontiersin.org/articles/10.3389/fcvm.2023.1021937/fullpyrotinibcardiotoxicityHER2-positive breast cancertherapy-related cardiac dysfunctionechocardiographymagnetic resonance |
| spellingShingle | Yezi Chai Meng Jiang Yaohui Wang Qiming Liu Qifan Lu Zhengyu Tao Qizhen Wu Wenjin Yin Jinsong Lu Jun Pu Protocol for pyrotinib cardiac safety in patients with HER2-positive early or locally advanced breast cancer–The EARLY-MYO-BC study Frontiers in Cardiovascular Medicine pyrotinib cardiotoxicity HER2-positive breast cancer therapy-related cardiac dysfunction echocardiography magnetic resonance |
| title | Protocol for pyrotinib cardiac safety in patients with HER2-positive early or locally advanced breast cancer–The EARLY-MYO-BC study |
| title_full | Protocol for pyrotinib cardiac safety in patients with HER2-positive early or locally advanced breast cancer–The EARLY-MYO-BC study |
| title_fullStr | Protocol for pyrotinib cardiac safety in patients with HER2-positive early or locally advanced breast cancer–The EARLY-MYO-BC study |
| title_full_unstemmed | Protocol for pyrotinib cardiac safety in patients with HER2-positive early or locally advanced breast cancer–The EARLY-MYO-BC study |
| title_short | Protocol for pyrotinib cardiac safety in patients with HER2-positive early or locally advanced breast cancer–The EARLY-MYO-BC study |
| title_sort | protocol for pyrotinib cardiac safety in patients with her2 positive early or locally advanced breast cancer the early myo bc study |
| topic | pyrotinib cardiotoxicity HER2-positive breast cancer therapy-related cardiac dysfunction echocardiography magnetic resonance |
| url | https://www.frontiersin.org/articles/10.3389/fcvm.2023.1021937/full |
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