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Набор скоро начнётся NCT07254221

Rosuvastatin for Prevention of Anthracycline-induced Cardiac Dysfunction in Breast Cancer Patients

Фаза IV С лечением Anthracycline-induced Cardiac Toxicity Breast Cancer Anthracycline Related Cardiotoxicity in Breast Cancer Anthracycline-induced Cardiotoxicity

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Rosuvastatin 20 mg/day, Placebo tablets similar to rosuvastatin 20mg tablets.
Кому может быть актуально
Состояния в реестре: Anthracycline-induced Cardiac Toxicity, Breast Cancer, Anthracycline Related Cardiotoxicity in Breast Cancer, Anthracycline-induced Cardiotoxicity. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Иран
Следующий шаг
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Официальное название

Evaluation of Rosuvastatin Efficacy in Prevention of Anthracycline-induced Cardiac Dysfunction in Breast Cancer Patients After Chemotherapy

Обзор

This study, called "ROSUBREAST", is a multicenter, double-blind, randomized clinical trial evaluating whether rosuvastatin (20 mg daily) can protect the heart in women with breast cancer receiving anthracycline-based chemotherapy. A total of 400 participants will be randomly assigned to receive either rosuvastatin or placebo for 12 months. The main goal is to determine whether rosuvastatin can prevent cancer treatment-related cardiac dysfunction (CTRCD), defined as a significant drop in heart pumping function. The study will also assess changes in cardiac strain, blood biomarkers, symptoms of heart failure, quality of life, and possible side effects.

Подробное описание

Introduction: Anthracycline-induced cardiotoxicity significantly threatens the long-term cardiac health of breast cancer patients undergoing chemotherapy. Statins have shown potential cardioprotective effects without compromising cancer treatment efficacy. The ROSUBREAST study aims to evaluate the efficacy of rosuvastatin in preventing CTRCD in breast cancer patients receiving anthracycline-based chemotherapy. Methods: This multicenter, two-arm, double-blinded, superiority, parallel-group, randomized, placebo controlled clinical trial will be conducted across seven oncocardiology centers in Iran. A total of 400 participants will be enrolled and will be randomly assigned in a 1:1 ratio to receive either rosuvastatin (20 mg daily) or no intervention for 12 months. The primary endpoint is the incidence of CTRCD, defined as a ≥10% reduction in left ventricular ejection fraction (LVEF) to below the lower normal limit (53%). Secondary endpoints include changes in Global Longitudinal Strain (GLS), biomarkers (Troponin, NT-proBNP, hsCRP), and development of heart failure (HF). Ancillary endpoints are quality-of-life assessments and adverse effects of treatment. Conclusion: The ROSUBREAST study seeks to provide evidence on the cardioprotective role of rosuvastatin in breast cancer patients undergoing anthracycline-based chemotherapy, potentially informing clinical guidelines and improving patient outcomes.

Вмешательства

  • Препарат Rosuvastatin 20 mg/day
    Consumption of rosuvastatin 20mg tablets every day
  • Препарат Placebo tablets similar to rosuvastatin 20mg tablets
    consumption of placebo tablets similar to rosuvastatin 20mg

Первичные конечные точки

  • CTRCD (cancer treatment-related cardiac dysfunction) [Срок оценки: 12 months after randomization]
Вторичные конечные точки (5)
  • changes in LVEF [Срок оценки: 3, 6, and 12 months after randomization]
  • changes in Global Longitudinal Strain (GLS) [Срок оценки: 3, 6, and 12 months after randomization]
  • changes in Troponin level [Срок оценки: 3, 6, and 12 months after randomization]
  • changes in N-terminal pro b-type Natriuretic Peptide (NT-proBNP) level [Срок оценки: 3, 6, and 12 months after randomization]
  • changes in High-sensitivity C-reactive Protein (hsCRP) level [Срок оценки: 3, 6, and 12 months after randomization]

Критерии участия

Критерии включения

  • Female individuals with ≥18 years of age
  • Documented breast cancer diagnosis based on imaging and pathology findings
  • Scheduled to receive the first time anthracycline-based chemotherapy

Критерии исключения

  • Baseline LVEF < 50%
  • Prior Statin use or Statin use is indicated based on guidelines
  • history of congestive heart failure (CHF) or cardiomyopathy
  • Pregnancy or breastfeeding
  • Unable to provide informed consent
  • Unexplained persistent elevation of transaminases (>3 times upper limits of normal)
  • Concomitant use of oral cyclosporine
  • Metastatic invasion of cancer to other organs
  • Previous cycles of chemotherapy
  • Any contraindication for statin use

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Профилактика

Центры проведения

Иран · 7 центров
  • Motahari Breast Cancer Clinic — Shiraz
  • Kowsar Hospital, Fars Heart Foundation — Shiraz
  • Toba Oncology Department, Mazandaran University of Medical Sciences — Sari
  • Modarres Hospital, Shahid Beheshti University of Medical Sciences — Tehran
  • Rajaee Hospital, Iran University of Medical Sciences — Tehran
  • Sina Hospital, Tehran University of Medical Sciences — Tehran
  • Taleghani Hospital, Shahid Beheshti University of Medical Sciences — Tehran

Идентификаторы

NCT: NCT07254221 · IR.SUMS.MED.REC.1404.351 · IRCT20191002044961N2

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗