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Breast CancerPhase 4B-BITNCT07583134

Impact of Propranolol Strategies on Myocardial Injury After Breast Cancer Surgery

A Phase 4 study testing propranolol in people with Breast Cancer and Myocardial Injury After Noncardiac Surgery (MINS), run by Chang-Ik Yoon at 1 site in South Korea.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 to 70 years, women only
What is being tested?
propranolol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteSouth Korea
Study dates
26 May 2026to 24 May 2033
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jinah Lee, MD contact

82-10-8573-9324

jinahsmile@naver.com

Chang Ik Yoon, MD, Ph.D. contact

82-10-8774-0103

fayn@daum.net

South Korea1 site

  • Seoul St. Mary's Hospital, The Catholic University of Korea

    Seoul, Seoul, 06591

    Jinah Lee, MD, 82-10-8573-9324, jinahsmile@naver.com

    Chang Ik Yoon, MD, Ph.D., 82-10-8774-0103, fayn@daum.net

Other trials in South Korea

About this study

Official title: 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.

Read the detailed description

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:

  1. Propranolol Group: Patients receive propranolol for at least 14 days before surgery.
  2. 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.
Being tested
propranolol, Usual Care
Keywords
Propranolol, Breast Cancer Surgery, Beta-blockers, Tumor Microenvironment, Pragmatic Clinical Trial
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • propranololDrug

    Propranolol (dosage based on clinical indication) for at least 14 days before surgery until the morning of the operation.

  • Usual CareOther

    Standard medical management (e.g., CCB, ACEi, ARB, or diuretics) at the physician's discretion, excluding beta-blockers.

Study groups in NCT07583134
Study groupRoleWhat they receive
Propranolol GroupExperimentalParticipants 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.
Receives: Drug: propranolol
Non-Propranolol Group (Usual Care)Active comparatorParticipants will receive standard clinical care for hypertension or angina without the use of Propranolol or other beta-blockers before surgery
Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Myocardial Injury after Noncardiac Surgery (MINS)

    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:

    1. 0.02-0.065 ng/mL with an absolute change of more than 0.005ng/mL or
    2. any elevation ≥0.065 ng/mL or any absolute change more than 0.014 ng/mL

    Measured: From the day of surgery (Day 0) up to 30 days postoperatively

Secondary outcomes (5)

  1. Perioperative Hemodynamic Stability: Systolic Blood Pressure Fluctuation

    Comparison of the fluctuation range of blood pressure during surgery and in the recovery room (up to 2hours post-surgery)

    Measured: During surgery and in the recovery room (up to 2hours post-surgery)(Day 0)

  2. Perioperative Hemodynamic Stability: Heart rate Fluctuation

    Comparison of the fluctuation range of Heart rate during surgery and in the recovery room (up to 2hours post-surgery)

    Measured: During surgery and in the recovery room (up to 2hours post-surgery)(Day 0)

  3. Postoperative Cardiovascular and Respiratory Complications Rate

    Incidence of major cardiovascular and respiratory complications, including MI, CVA, MINS, and pulmonary complications.

    Measured: Within 30 days after surgery

  4. length of hospital stay

    Total number of days from the date of surgery to the date of discharge.

    Measured: Within 30 days after surgery

  5. Change in Patient-Reported Anxiety (HADS-A)

    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.

    Measured: Baseline (Screening), Just before surgery (Day 0), and 6 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2026
  2. Study start26 May 2026 (estimated)
  3. Primary completion23 May 2028 (estimated)
  4. Study completion24 May 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a prospective, randomized, open-label, two-arm, single-center pragmatic clinical trial. Eligible patients are randomized in a 1:1 ratio into either the Propranolol group or the Non-propranolol group, stratified by cancer stage (Stage 1 vs. Stage 2/3). The study evaluates the real-world clinical impact of preoperative propranolol administration on postoperative myocardial injury.
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07583134
Sponsor's protocol ID
KC26MISV0115
Other IDs
KCT0011912
Acronym
B-BIT
Status last verified
May 2026
First submitted
27 Apr 2026
Last updated
15 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40652143

  • 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.

    PubMed 31754048

  • 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.

    PubMed 22706835

  • 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.

    PubMed 24534856

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing propranolol in people with Breast Cancer and Myocardial Injury After Noncardiac Surgery (MINS), run by Chang-Ik Yoon at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jinah Lee, MD (82-10-8573-9324, jinahsmile@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Myocardial Injury after Noncardiac Surgery (MINS) (time frame: From the day of surgery (Day 0) up to 30 days postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07583134, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.

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