Impact of Propranolol Strategies on Myocardial Injury After Breast Cancer Surgery (B-BIT)
12 mai 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
100
Phase
- Phase 4
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Jinah Lee, MD
- Numéro de téléphone: 82-10-8573-9324
- E-mail: jinahsmile@naver.com
Sauvegarde des contacts de l'étude
- Nom: Chang Ik Yoon, MD, Ph.D.
- Numéro de téléphone: 82-10-8774-0103
- E-mail: fayn@daum.net
Lieux d'étude
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Seoul
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Seoul, Seoul, Corée du Sud, 06591
- Seoul St. Mary's Hospital, The Catholic University of Korea
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Contact:
- Jinah Lee, MD
- Numéro de téléphone: 82-10-8573-9324
- E-mail: jinahsmile@naver.com
-
Contact:
- Chang Ik Yoon, MD, Ph.D.
- Numéro de téléphone: 82-10-8774-0103
- E-mail: fayn@daum.net
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Incidence of Myocardial Injury after Noncardiac Surgery (MINS)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Perioperative Hemodynamic Stability: Systolic Blood Pressure Fluctuation
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Tumor Microenvironment and Biological Markers: Ki-67 Proliferation Index
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Chang Ik Yoon, MD, Ph.D., Seoul St. Mary's Hospital, The Catholic University of Korea
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
26 mai 2026
Achèvement primaire (Estimé)
23 mai 2028
Achèvement de l'étude (Estimé)
24 mai 2033
Dates d'inscription aux études
Première soumission
27 avril 2026
Première soumission répondant aux critères de contrôle qualité
6 mai 2026
Première publication (Réel)
13 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
15 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Tumeurs par site
- Tumeurs
- Maladies de la peau
- Maladies du sein
- Maladies de la peau et du tissu conjonctif
- Tumeurs mammaires
- Produits chimiques organiques
- Hydrocarbures
- Hydrocarbures, cyclique
- Naphtalenes
- Hydrocarbures aromatiques polycycliques
- Hydrocarbures, aromatique
- Composés polycycliques
- Amines
- Alcools
- Phénoxypropanolamines
- Propanolamines
- Alcools amino
- Propanols
- Propranolol
Autres numéros d'identification d'étude
- KC26MISV0115
- KCT0011912 (Autre identifiant: Clinical Research Information Service)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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