Impact of Propranolol Strategies on Myocardial Injury After Breast Cancer Surgery (B-BIT)
12 de mayo de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
100
Fase
- Fase 4
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Jinah Lee, MD
- Número de teléfono: 82-10-8573-9324
- Correo electrónico: jinahsmile@naver.com
Copia de seguridad de contactos de estudio
- Nombre: Chang Ik Yoon, MD, Ph.D.
- Número de teléfono: 82-10-8774-0103
- Correo electrónico: fayn@daum.net
Ubicaciones de estudio
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Seoul
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Seoul, Seoul, Corea del Sur, 06591
- Seoul St. Mary's Hospital, The Catholic University of Korea
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Contacto:
- Jinah Lee, MD
- Número de teléfono: 82-10-8573-9324
- Correo electrónico: jinahsmile@naver.com
-
Contacto:
- Chang Ik Yoon, MD, Ph.D.
- Número de teléfono: 82-10-8774-0103
- Correo electrónico: fayn@daum.net
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of Myocardial Injury after Noncardiac Surgery (MINS)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Perioperative Hemodynamic Stability: Systolic Blood Pressure Fluctuation
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Tumor Microenvironment and Biological Markers: Ki-67 Proliferation Index
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: Baseline (Screening), Day 0 (Surgery), and 6 months after surgery
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Comparison of changes in lactate dehydrogenase (LDH)
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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: Carcinoembryonic Antigen (CEA)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: Up to 5 years after surgery
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Descriptive analysis of recurrence status, invasive disease-free survival (iDFS), and overall survival (OS)
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Up to 5 years after surgery
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Molecular and Immunological Analysis
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Chang Ik Yoon, MD, Ph.D., Seoul St. Mary's Hospital, The Catholic University of Korea
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
26 de mayo de 2026
Finalización primaria (Estimado)
23 de mayo de 2028
Finalización del estudio (Estimado)
24 de mayo de 2033
Fechas de registro del estudio
Enviado por primera vez
27 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
6 de mayo de 2026
Publicado por primera vez (Actual)
13 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
12 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Enfermedades de la piel
- Enfermedades de los senos
- Enfermedades de la piel y del tejido conectivo
- Neoplasias de mama
- Químicos orgánicos
- Hidrocarburos
- Hidrocarburos, cíclico
- Naftalenos
- Hidrocarburos aromáticos policíclicos
- Hidrocarburos, aromáticos
- Compuestos policíclicos
- Amina
- Alcoholes
- Fenoxipropanolaminas
- Propanolaminas
- Amino alcoholes
- Propanols
- Propranolol
Otros números de identificación del estudio
- KC26MISV0115
- KCT0011912 (Otro identificador: Clinical Research Information Service)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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