Momoko Tokura, Mark Malalay Ando, Yuki Kojima, Rui Kitadai, Shu Yazaki, Cyrielle Marie N Atutubo, Rubi K Li, Minda Z Perez, Agnes E Gorospe, Manuelito A Madrid, Mel Valerie C Ordinario, Marcelo Severino B Imasa, Kazuki Sudo, Tatsunori Shimoi, Akihiko Suto, Shinji Kohsaka, Ryunosuke Machida, Ryo Sadachi, Masayuki Yoshida, Yasushi Yatabe, Tomomi Hata, Kenichi Nakamura, Kan Yonemori, Sho Shiino
{"title":"通过循环肿瘤 DNA 分析检测 HER2 阳性早期乳腺癌微小残留病灶并配合新辅助化疗的多中心前瞻性研究：HARMONY 研究。","authors":"Momoko Tokura, Mark Malalay Ando, Yuki Kojima, Rui Kitadai, Shu Yazaki, Cyrielle Marie N Atutubo, Rubi K Li, Minda Z Perez, Agnes E Gorospe, Manuelito A Madrid, Mel Valerie C Ordinario, Marcelo Severino B Imasa, Kazuki Sudo, Tatsunori Shimoi, Akihiko Suto, Shinji Kohsaka, Ryunosuke Machida, Ryo Sadachi, Masayuki Yoshida, Yasushi Yatabe, Tomomi Hata, Kenichi Nakamura, Kan Yonemori, Sho Shiino","doi":"10.1177/11782234241288671","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Biomarkers to predict the recurrence risk are required to optimize perioperative treatment. Adjuvant chemotherapy for patients with human epidermal growth factor 2-positive (HER2-positive) early breast cancer is decided by pathological responses of neoadjuvant chemotherapy (NAC). However, whether pathological responses are appropriate biomarkers is unclear. Currently, there are several studies using minimal residual disease (MRD) as a predictor of prognosis in solid tumors. However, there is no standard method for detecting MRD.</p><p><strong>Objectives: </strong>This study aimed at prospectively evaluating the relationship between MRD detection and recurrence in Asian patients with HER2-positive early breast cancer.</p><p><strong>Design: </strong>Prospective, observational, single-group, and exploratory. This study will include 60 patients from 2 institutions in Japan and the Philippines. The invasive disease-free survival (IDFS) rates of the MRD-positive and MRD-negative groups are compared in patients with HER2-positive early breast cancer who undergo surgery after receiving NAC.</p><p><strong>Methods and analysis: </strong>Circulating tumor DNA (ctDNA) levels of patients will be evaluated 6 times: before NAC, after NAC, after surgery, and annually after surgery for 3 years. We will analyze the genetic profile of blood and tissue samples using the Todai OncoPanel (TOP) and the methylation level of DNA. The primary endpoint is IDFS. Secondary endpoints include overall survival (OS) and disease-free survival (DFS). Patient enrollment began in June 2022, and new participants are still being recruited.</p><p><strong>Ethics: </strong>This study has been approved by the National Cancer Center Hospital Certified Review Board in March 2022 and has been approved by the Research Ethics Board of the participating center.</p><p><strong>Discussion: </strong>Our findings will contribute to determining whether MRD detection using TOP is useful for predicting the recurrence of HER2-positive early breast cancer. If this is proven, MRD detected by TOP could be used in the future as a biomarker to assist in the de-/escalation of treatment strategies in the next interventional trial, thereby avoiding overtreatment in patients at low risk, and in the addition of intensive treatment modalities for those in patients at high risk.</p>","PeriodicalId":9163,"journal":{"name":"Breast Cancer : Basic and Clinical Research","volume":"18 ","pages":"11782234241288671"},"PeriodicalIF":1.8000,"publicationDate":"2024-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11528640/pdf/","citationCount":"0","resultStr":"{\"title\":\"Multicenter Prospective Study in HER2-Positive Early Breast Cancer for Detecting Minimal Residual Disease by Circulating Tumor DNA Analysis With Neoadjuvant Chemotherapy: HARMONY Study.\",\"authors\":\"Momoko Tokura, Mark Malalay Ando, Yuki Kojima, Rui Kitadai, Shu Yazaki, Cyrielle Marie N Atutubo, Rubi K Li, Minda Z Perez, Agnes E Gorospe, Manuelito A Madrid, Mel Valerie C Ordinario, Marcelo Severino B Imasa, Kazuki Sudo, Tatsunori Shimoi, Akihiko Suto, Shinji Kohsaka, Ryunosuke Machida, Ryo Sadachi, Masayuki Yoshida, Yasushi Yatabe, Tomomi Hata, Kenichi Nakamura, Kan Yonemori, Sho Shiino\",\"doi\":\"10.1177/11782234241288671\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Biomarkers to predict the recurrence risk are required to optimize perioperative treatment. Adjuvant chemotherapy for patients with human epidermal growth factor 2-positive (HER2-positive) early breast cancer is decided by pathological responses of neoadjuvant chemotherapy (NAC). However, whether pathological responses are appropriate biomarkers is unclear. Currently, there are several studies using minimal residual disease (MRD) as a predictor of prognosis in solid tumors. However, there is no standard method for detecting MRD.</p><p><strong>Objectives: </strong>This study aimed at prospectively evaluating the relationship between MRD detection and recurrence in Asian patients with HER2-positive early breast cancer.</p><p><strong>Design: </strong>Prospective, observational, single-group, and exploratory. This study will include 60 patients from 2 institutions in Japan and the Philippines. The invasive disease-free survival (IDFS) rates of the MRD-positive and MRD-negative groups are compared in patients with HER2-positive early breast cancer who undergo surgery after receiving NAC.</p><p><strong>Methods and analysis: </strong>Circulating tumor DNA (ctDNA) levels of patients will be evaluated 6 times: before NAC, after NAC, after surgery, and annually after surgery for 3 years. We will analyze the genetic profile of blood and tissue samples using the Todai OncoPanel (TOP) and the methylation level of DNA. The primary endpoint is IDFS. Secondary endpoints include overall survival (OS) and disease-free survival (DFS). Patient enrollment began in June 2022, and new participants are still being recruited.</p><p><strong>Ethics: </strong>This study has been approved by the National Cancer Center Hospital Certified Review Board in March 2022 and has been approved by the Research Ethics Board of the participating center.</p><p><strong>Discussion: </strong>Our findings will contribute to determining whether MRD detection using TOP is useful for predicting the recurrence of HER2-positive early breast cancer. If this is proven, MRD detected by TOP could be used in the future as a biomarker to assist in the de-/escalation of treatment strategies in the next interventional trial, thereby avoiding overtreatment in patients at low risk, and in the addition of intensive treatment modalities for those in patients at high risk.</p>\",\"PeriodicalId\":9163,\"journal\":{\"name\":\"Breast Cancer : Basic and Clinical Research\",\"volume\":\"18 \",\"pages\":\"11782234241288671\"},\"PeriodicalIF\":1.8000,\"publicationDate\":\"2024-10-27\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11528640/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Breast Cancer : Basic and Clinical Research\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1177/11782234241288671\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q3\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Breast Cancer : Basic and Clinical Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/11782234241288671","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/1/1 0:00:00","PubModel":"eCollection","JCR":"Q3","JCRName":"ONCOLOGY","Score":null,"Total":0}
Multicenter Prospective Study in HER2-Positive Early Breast Cancer for Detecting Minimal Residual Disease by Circulating Tumor DNA Analysis With Neoadjuvant Chemotherapy: HARMONY Study.
Background: Biomarkers to predict the recurrence risk are required to optimize perioperative treatment. Adjuvant chemotherapy for patients with human epidermal growth factor 2-positive (HER2-positive) early breast cancer is decided by pathological responses of neoadjuvant chemotherapy (NAC). However, whether pathological responses are appropriate biomarkers is unclear. Currently, there are several studies using minimal residual disease (MRD) as a predictor of prognosis in solid tumors. However, there is no standard method for detecting MRD.
Objectives: This study aimed at prospectively evaluating the relationship between MRD detection and recurrence in Asian patients with HER2-positive early breast cancer.
Design: Prospective, observational, single-group, and exploratory. This study will include 60 patients from 2 institutions in Japan and the Philippines. The invasive disease-free survival (IDFS) rates of the MRD-positive and MRD-negative groups are compared in patients with HER2-positive early breast cancer who undergo surgery after receiving NAC.
Methods and analysis: Circulating tumor DNA (ctDNA) levels of patients will be evaluated 6 times: before NAC, after NAC, after surgery, and annually after surgery for 3 years. We will analyze the genetic profile of blood and tissue samples using the Todai OncoPanel (TOP) and the methylation level of DNA. The primary endpoint is IDFS. Secondary endpoints include overall survival (OS) and disease-free survival (DFS). Patient enrollment began in June 2022, and new participants are still being recruited.
Ethics: This study has been approved by the National Cancer Center Hospital Certified Review Board in March 2022 and has been approved by the Research Ethics Board of the participating center.
Discussion: Our findings will contribute to determining whether MRD detection using TOP is useful for predicting the recurrence of HER2-positive early breast cancer. If this is proven, MRD detected by TOP could be used in the future as a biomarker to assist in the de-/escalation of treatment strategies in the next interventional trial, thereby avoiding overtreatment in patients at low risk, and in the addition of intensive treatment modalities for those in patients at high risk.
期刊介绍：
Breast Cancer: Basic and Clinical Research is an international, open access, peer-reviewed, journal which considers manuscripts on all areas of breast cancer research and treatment. We welcome original research, short notes, case studies and review articles related to breast cancer-related research. Specific areas of interest include, but are not limited to, breast cancer sub types, pathobiology, metastasis, genetics and epigenetics, mammary gland biology, breast cancer models, prevention, detection, therapy and clinical interventions, and epidemiology and population genetics.
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