Impact of Propranolol Strategies on Myocardial Injury After Breast Cancer Surgery (B-BIT)
2026年5月12日 更新者：Chang-Ik Yoon
A Pragmatic Clinical Trial to Evaluate the Impact of Clinical Propranolol Strategies on Myocardial Injury After Non-cardiac Surgery (MINS) in Patients Undergoing Breast Cancer Surgery With Hypertension or Angina
This study aims to evaluate the impact of using propranolol, a non-selective beta-blocker, on preventing myocardial injury after non-cardiac surgery (MINS) in breast cancer patients who also have hypertension or angina.
Stress from surgery and anesthesia can increase sympathetic activity and inflammation, which may lead to heart stress.
This pragmatic clinical trial will compare patients who are prescribed propranolol as part of their routine care with those who are not.
Researchers will analyze blood samples and surgical tissues collected during normal treatment to observe changes in heart health and the tumor microenvironment.
研究概览
详细说明
Breast cancer is the most common malignancy among women in Korea. Perioperative stress and acute physiological stimuli from surgery and anesthesia increase catecholamine secretion, which can lead to Myocardial Injury after Non-cardiac Surgery (MINS). Propranolol is known to stabilize hemodynamic variability by inhibiting sympathetic surge and reducing myocardial oxygen consumption. Recent studies also suggest that beta-blockers may influence the tumor microenvironment (TME) by reducing inflammation and regulating immune cell composition.This prospective, randomized, open-label, single-center pragmatic clinical trial will enroll 100 female patients (aged 20-70) with stage I-III breast cancer and comorbid hypertension or angina. Participants will be randomized 1:1 into two groups:
- Propranolol Group: Patients receive propranolol for at least 14 days before surgery.
- Non-Propranolol Group: Patients receive usual care without propranolol.The primary objective is to compare the incidence of MINS based on high-sensitivity Troponin T (hs-TnT) levels measured postoperatively. Exploratory objectives include analyzing markers of inflammation (CRP, LDH), tumor proliferation (Ki-67), and tumor-infiltrating lymphocytes (TILs) using blood and tissue samples naturally obtained during the clinical process. Long-term follow-up will be conducted for up to 5 years to evaluate recurrence and survival outcomes.
研究类型
介入性
注册 (估计的)
100
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Jinah Lee, MD
- 电话号码：82-10-8573-9324
- 邮箱：jinahsmile@naver.com
研究联系人备份
- 姓名：Chang Ik Yoon, MD, Ph.D.
- 电话号码：82-10-8774-0103
- 邮箱：fayn@daum.net
学习地点
-
-
Seoul
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Seoul、Seoul、韩国、06591
- Seoul St. Mary's Hospital, The Catholic University of Korea
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接触：
- Jinah Lee, MD
- 电话号码：82-10-8573-9324
- 邮箱：jinahsmile@naver.com
-
接触：
- Chang Ik Yoon, MD, Ph.D.
- 电话号码：82-10-8774-0103
- 邮箱：fayn@daum.net
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Female patients aged 20 to 70 years.
- Patients diagnosed with hypertension or angina who require medication.
- Patients diagnosed with unilateral, resectable primary breast cancer (ICD-10: C50), Stage I-III.
- ECOG performance status of 0-1.
- Patients scheduled to receive standard postoperative treatment (including adjuvant radiotherapy
- Patients who voluntarily decide to participate and sign the written informed consent form
Exclusion Criteria:
- Patients with distant metastases.
- Patients with active infectious diseases, autoimmune diseases (including specific rheumatic diseases), coagulation disorders, or cardiovascular diseases other than hypertension or angina pectoris.
Patients with clinically significant hepatic, hematologic, or renal dysfunction, defined as any of the following:
① ANC <1,500/mm3
Platelets <100,000/mm3
Hb <9 g/dL
- AST and ALT > 2.5 x upper limit of normal (ULN) ⑤ Alkaline phosphatase > 2.5 x ULN ⑥ Total bilirubin > 1 x ULN ⑦ Serum creatinine >1.5 x ULN or estimated creatinine clearance < 60 mL/min (as calculated using the method standard for the institution)
- Patients with moderate to severe asthma or chronic obstructive pulmonary disease (COPD).
- Patients who are pregnant or breastfeeding at the time of enrollment.
- Patients with a history of malignancy within the past 5 years.
- Patients for whom data collection is considered difficult at the discretion of the investigator.
- Patients who are unable to understand or complete study questionnaires.
- Patients who have received β-blockers within 30 days prior to screening.
- Patients with systolic blood pressure < 100 mmHg or heart rate < 55 beats per minute.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Propranolol Group
Participants with hypertension or angina undergoing breast cancer surgery will receive Propranolol (dosage based on clinical indication) for at least 14 days before surgery until the morning of the operation.
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Propranolol (dosage based on clinical indication) for at least 14 days before surgery until the morning of the operation.
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有源比较器：Non-Propranolol Group (Usual Care)
Participants will receive standard clinical care for hypertension or angina without the use of Propranolol or other beta-blockers before surgery
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Standard medical management (e.g., CCB, ACEi, ARB, or diuretics) at the physician's discretion, excluding beta-blockers.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of Myocardial Injury after Noncardiac Surgery (MINS)
大体时间：From the day of surgery (Day 0) up to 30 days postoperatively
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MINS is defined as an elevated high-sensitivity cardiac Troponin T (hs-TnT) level measured for clinical purposes after surgery that exceeds the 99th percentile upper reference limit. Specifically, it is defined as:
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From the day of surgery (Day 0) up to 30 days postoperatively
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Perioperative Hemodynamic Stability: Systolic Blood Pressure Fluctuation
大体时间：During surgery and in the recovery room (up to 2hours post-surgery)(Day 0)
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Comparison of the fluctuation range of blood pressure during surgery and in the recovery room (up to 2hours post-surgery)
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During surgery and in the recovery room (up to 2hours post-surgery)(Day 0)
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Perioperative Hemodynamic Stability: Heart rate Fluctuation
大体时间：During surgery and in the recovery room (up to 2hours post-surgery)(Day 0)
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Comparison of the fluctuation range of Heart rate during surgery and in the recovery room (up to 2hours post-surgery)
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During surgery and in the recovery room (up to 2hours post-surgery)(Day 0)
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Postoperative Cardiovascular and Respiratory Complications Rate
大体时间：Within 30 days after surgery
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Incidence of major cardiovascular and respiratory complications, including MI, CVA, MINS, and pulmonary complications.
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Within 30 days after surgery
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length of hospital stay
大体时间：Within 30 days after surgery
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Total number of days from the date of surgery to the date of discharge.
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Within 30 days after surgery
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Change in Patient-Reported Anxiety (HADS-A)
大体时间：Baseline (Screening), Just before surgery (Day 0), and 6 months after surgery
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Evaluation of the change in anxiety levels using the Hospital Anxiety and Depression Scale-Anxiety (HADS-A) subscale.
The score ranges from 0 to 21, with higher scores indicating higher anxiety.
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Baseline (Screening), Just before surgery (Day 0), and 6 months after surgery
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Tumor Microenvironment and Biological Markers: Ki-67 Proliferation Index
大体时间：At the time of surgery (Day 0)
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The percentage of Ki-67 positive tumor cells measured by immunohistochemistry in surgical tissues.
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At the time of surgery (Day 0)
|
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Tumor Microenvironment and Biological Markers: Histological Grade
大体时间：At the time of surgery (Day 0)
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Assessment of tumor differentiation using the Modified Bloom-Richardson grade.
The scale ranges from 3 to 9, where higher scores indicate a more aggressive tumor/worse outcome.
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At the time of surgery (Day 0)
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Tumor Microenvironment and Biological Markers: Presence of Lymphovascular Invasion
大体时间：At the time of surgery (Day 0)
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Pathological assessment of the presence or absence of tumor cells within lymphatic or vascular channels in the surgical specimen.
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At the time of surgery (Day 0)
|
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Tumor Microenvironment and Biological Markers: Tumor-Infiltrating Lymphocytes (TILs)
大体时间：At the time of surgery (Day 0)
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Percentage of stromal area occupied by mononuclear inflammatory cells in the surgical specimen.
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At the time of surgery (Day 0)
|
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Changes in Inflammatory Markers and Serum Tumor Markers: C-Reactive Protein (CRP)
大体时间：Baseline (Screening), Day 0 (Surgery), and 6 months after surgery
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Comparison of changes in C-reactive protein (CRP)
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Baseline (Screening), Day 0 (Surgery), and 6 months after surgery
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Changes in Inflammatory Markers and Serum Tumor Markers: lactate dehydrogenase (LDH)
大体时间：Baseline (Screening), Day 0 (Surgery), and 6 months after surgery
|
Comparison of changes in lactate dehydrogenase (LDH)
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Baseline (Screening), Day 0 (Surgery), and 6 months after surgery
|
|
Changes in Inflammatory Markers and Serum Tumor Markers: Carcinoembryonic Antigen (CEA)
大体时间：Baseline (Screening), Day 0 (Surgery), and 6 months after surgery
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Comparison of changes in serum tumor marker CEA
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Baseline (Screening), Day 0 (Surgery), and 6 months after surgery
|
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Changes in Inflammatory Markers and Serum Tumor Markers: Cancer Antigen 15-3 (CA 15-3)
大体时间：Baseline (Screening), Day 0 (Surgery), and 6 months after surgery
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Comparison of changes in serum tumor markers CA 15-3
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Baseline (Screening), Day 0 (Surgery), and 6 months after surgery
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Long-term Recurrence and Survival Outcomes
大体时间：Up to 5 years after surgery
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Descriptive analysis of recurrence status, invasive disease-free survival (iDFS), and overall survival (OS)
|
Up to 5 years after surgery
|
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Molecular and Immunological Analysis
大体时间：Up to 5 years (duration of sample storage and analysis)
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Exploration of biological changes related to propranolol use through molecular analysis (e.g., RNA/DNA sequencing) using stored tissue and blood samples.
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Up to 5 years (duration of sample storage and analysis)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Chang Ik Yoon, MD, Ph.D.、Seoul St. Mary's Hospital, The Catholic University of Korea
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Botto F, Alonso-Coello P, Chan MT, Villar JC, Xavier D, Srinathan S, Guyatt G, Cruz P, Graham M, Wang CY, Berwanger O, Pearse RM, Biccard BM, Abraham V, Malaga G, Hillis GS, Rodseth RN, Cook D, Polanczyk CA, Szczeklik W, Sessler DI, Sheth T, Ackland GL, Leuwer M, Garg AX, Lemanach Y, Pettit S, Heels-Ansdell D, Luratibuse G, Walsh M, Sapsford R, Schunemann HJ, Kurz A, Thomas S, Mrkobrada M, Thabane L, Gerstein H, Paniagua P, Nagele P, Raina P, Yusuf S, Devereaux PJ, Devereaux PJ, Sessler DI, Walsh M, Guyatt G, McQueen MJ, Bhandari M, Cook D, Bosch J, Buckley N, Yusuf S, Chow CK, Hillis GS, Halliwell R, Li S, Lee VW, Mooney J, Polanczyk CA, Furtado MV, Berwanger O, Suzumura E, Santucci E, Leite K, Santo JA, Jardim CA, Cavalcanti AB, Guimaraes HP, Jacka MJ, Graham M, McAlister F, McMurtry S, Townsend D, Pannu N, Bagshaw S, Bessissow A, Bhandari M, Duceppe E, Eikelboom J, Ganame J, Hankinson J, Hill S, Jolly S, Lamy A, Ling E, Magloire P, Pare G, Reddy D, Szalay D, Tittley J, Weitz J, Whitlock R, Darvish-Kazim S, Debeer J, Kavsak P, Kearon C, Mizera R, O'Donnell M, McQueen M, Pinthus J, Ribas S, Simunovic M, Tandon V, Vanhelder T, Winemaker M, Gerstein H, McDonald S, O'Bryne P, Patel A, Paul J, Punthakee Z, Raymer K, Salehian O, Spencer F, Walter S, Worster A, Adili A, Clase C, Cook D, Crowther M, Douketis J, Gangji A, Jackson P, Lim W, Lovrics P, Mazzadi S, Orovan W, Rudkowski J, Soth M, Tiboni M, Acedillo R, Garg A, Hildebrand A, Lam N, Macneil D, Mrkobrada M, Roshanov PS, Srinathan SK, Ramsey C, John PS, Thorlacius L, Siddiqui FS, Grocott HP, McKay A, Lee TW, Amadeo R, Funk D, McDonald H, Zacharias J, Villar JC, Cortes OL, Chaparro MS, Vasquez S, Castaneda A, Ferreira S, Coriat P, Monneret D, Goarin JP, Esteve CI, Royer C, Daas G, Chan MT, Choi GY, Gin T, Lit LC, Xavier D, Sigamani A, Faruqui A, Dhanpal R, Almeida S, Cherian J, Furruqh S, Abraham V, Afzal L, George P, Mala S, Schunemann H, Muti P, Vizza E, Wang CY, Ong GS, Mansor M, Tan AS, Shariffuddin II, Vasanthan V, Hashim NH, Undok AW, Ki U, Lai HY, Ahmad WA, Razack AH, Malaga G, Valderrama-Victoria V, Loza-Herrera JD, De Los Angeles Lazo M, Rotta-Rotta A, Szczeklik W, Sokolowska B, Musial J, Gorka J, Iwaszczuk P, Kozka M, Chwala M, Raczek M, Mrowiecki T, Kaczmarek B, Biccard B, Cassimjee H, Gopalan D, Kisten T, Mugabi A, Naidoo P, Naidoo R, Rodseth R, Skinner D, Torborg A, Paniagua P, Urrutia G, Maestre ML, Santalo M, Gonzalez R, Font A, Martinez C, Pelaez X, De Antonio M, Villamor JM, Garcia JA, Ferre MJ, Popova E, Alonso-Coello P, Garutti I, Cruz P, Fernandez C, Palencia M, Diaz S, Del Castillo T, Varela A, de Miguel A, Munoz M, Pineiro P, Cusati G, Del Barrio M, Membrillo MJ, Orozco D, Reyes F, Sapsford RJ, Barth J, Scott J, Hall A, Howell S, Lobley M, Woods J, Howard S, Fletcher J, Dewhirst N, Williams C, Rushton A, Welters I, Leuwer M, Pearse R, Ackland G, Khan A, Niebrzegowska E, Benton S, Wragg A, Archbold A, Smith A, McAlees E, Ramballi C, Macdonald N, Januszewska M, Stephens R, Reyes A, Paredes LG, Sultan P, Cain D, Whittle J, Del Arroyo AG, Sessler DI, Kurz A, Sun Z, Finnegan PS, Egan C, Honar H, Shahinyan A, Panjasawatwong K, Fu AY, Wang S, Reineks E, Nagele P, Blood J, Kalin M, Gibson D, Wildes T; Vascular events In noncardiac Surgery patIents cOhort evaluatioN (VISION) Writing Group, on behalf of The Vascular events In noncardiac Surgery patIents cOhort evaluatioN (VISION) Investigators; Appendix 1. The Vascular events In noncardiac Surgery patIents cOhort evaluatioN (VISION) Study Investigators Writing Group; Appendix 2. The Vascular events In noncardiac Surgery patIents cOhort evaluatioN Operations Committee; Vascular events In noncardiac Surgery patIents cOhort evaluatioN VISION Study Investigators. Myocardial injury after noncardiac surgery: a large, international, prospective cohort study establishing diagnostic criteria, characteristics, predictors, and 30-day outcomes. Anesthesiology. 2014 Mar;120(3):564-78. doi: 10.1097/ALN.0000000000000113.
- Vascular Events In Noncardiac Surgery Patients Cohort Evaluation (VISION) Study Investigators; Devereaux PJ, Chan MT, Alonso-Coello P, Walsh M, Berwanger O, Villar JC, Wang CY, Garutti RI, Jacka MJ, Sigamani A, Srinathan S, Biccard BM, Chow CK, Abraham V, Tiboni M, Pettit S, Szczeklik W, Lurati Buse G, Botto F, Guyatt G, Heels-Ansdell D, Sessler DI, Thorlund K, Garg AX, Mrkobrada M, Thomas S, Rodseth RN, Pearse RM, Thabane L, McQueen MJ, VanHelder T, Bhandari M, Bosch J, Kurz A, Polanczyk C, Malaga G, Nagele P, Le Manach Y, Leuwer M, Yusuf S. Association between postoperative troponin levels and 30-day mortality among patients undergoing noncardiac surgery. JAMA. 2012 Jun 6;307(21):2295-304. doi: 10.1001/jama.2012.5502.
- O'Logbon J, Tarantola L, Williams NR, Mehta S, Ahmed A, Davies EA. Does propranolol have a role in cancer treatment? A systematic review of the epidemiological and clinical trial literature on beta-blockers. J Cancer Res Clin Oncol. 2025 Jul 12;151(7):212. doi: 10.1007/s00432-025-06262-2.
- Hiller JG, Cole SW, Crone EM, Byrne DJ, Shackleford DM, Pang JB, Henderson MA, Nightingale SS, Ho KM, Myles PS, Fox S, Riedel B, Sloan EK. Preoperative beta-Blockade with Propranolol Reduces Biomarkers of Metastasis in Breast Cancer: A Phase II Randomized Trial. Clin Cancer Res. 2020 Apr 15;26(8):1803-1811. doi: 10.1158/1078-0432.CCR-19-2641. Epub 2019 Nov 21.
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年5月26日
初级完成 (估计的)
2028年5月23日
研究完成 (估计的)
2033年5月24日
研究注册日期
首次提交
2026年4月27日
首先提交符合 QC 标准的
2026年5月6日
首次发布 (实际的)
2026年5月13日
研究记录更新
最后更新发布 (实际的)
2026年5月15日
上次提交的符合 QC 标准的更新
2026年5月12日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- KC26MISV0115
- KCT0011912 (其他标识符：Clinical Research Information Service)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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