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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
100
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Jinah Lee, MD
- 電話番号：82-10-8573-9324
- メール：jinahsmile@naver.com
研究連絡先のバックアップ
- 名前：Chang Ik Yoon, MD, Ph.D.
- 電話番号：82-10-8774-0103
- メール：fayn@daum.net
研究場所
-
-
Seoul
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Seoul、Seoul、韓国、06591
- Seoul St. Mary's Hospital, The Catholic University of Korea
-
コンタクト：
- Jinah Lee, MD
- 電話番号：82-10-8573-9324
- メール：jinahsmile@naver.com
-
コンタクト：
- Chang Ik Yoon, MD, Ph.D.
- 電話番号：82-10-8774-0103
- メール：fayn@daum.net
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of Myocardial Injury after Noncardiac Surgery (MINS)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Perioperative Hemodynamic Stability: Systolic Blood Pressure Fluctuation
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Tumor Microenvironment and Biological Markers: Ki-67 Proliferation Index
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Chang Ik Yoon, MD, Ph.D.、Seoul St. Mary's Hospital, The Catholic University of Korea
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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便利なリンク
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年5月26日
一次修了 (推定)
2028年5月23日
研究の完了 (推定)
2033年5月24日
試験登録日
最初に提出
2026年4月27日
QC基準を満たした最初の提出物
2026年5月6日
最初の投稿 (実際)
2026年5月13日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月15日
QC基準を満たした最後の更新が送信されました
2026年5月12日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- KC26MISV0115
- KCT0011912 (その他の識別子：Clinical Research Information Service)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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