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NCT Number: NCT05338723

Possible Protective Effect of Rosuvastatin in Chemotherapy-induced Cardiotoxicity in HER2 Positive Breast Cancer Patients

This study aims to investigate the possible role of rosuvastatin in protection against cardiotoxicity in HER2 positive breast cancer patients receiving doxorubicin sequential with trastuzumab.

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Key information

Conditions

Chemotherapy-induced Cardiotoxicity Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

25 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

The Department of Clinical Oncology, Tanta University Hospital

Tanta, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 25-75 years old.
  • Gender: female
  • Newly diagnosed HER2 positive breast cancer patients who are scheduled to receive doxorubicin followed by trastuzumab adjuvant therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
  • Preserved LV systolic function in which the left ventricular ejection fraction (LVEF)≥50%.
  • Patients with normal renal and hematological functions.
  • Alanine amino transferase (ALT ≤ 3 times ULN).

Exclusion criteria

  • Pregnant or lactating females.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) > 2
  • Patients with impaired LV systolic function in which the left ventricular ejection fraction (LVEF)<50%.
  • Patients with significant valvular heart disease, documented coronary artery disease, history of congestive heart failure or cardiomyopathy.
  • Alanine amino transferase (ALT > 3 times ULN).
  • Patients already taking statins or other lipid lowering therapy.
  • Patients with a known hypersensitivity to any of the used drugs.

Treatment and study plan

Rosuvastatin 20mg

Drug

20 mg of oral rosuvastatin 24 hours prior to the first cycle of chemotherapy and once daily for the rest of the follow-up period (6 months).

Primary outcomes

  1. change in left ventricular ejection fraction(LVEF) detected by electrocardiography transthoracic echocardiography

    Time frame: 6 months

    Patients will undergo transthoracic echocardiography 24 hours prior to the initiation of chemotherapy, after 3 months and after 6 months to detect change in LVEF

Secondary outcomes

  1. change of serum level of High sensitivity troponin I (hs-TnI).

    Time frame: 6 months

    Blood samples will be collected at baseline, after 3 months and after 6 months to evaluate High sensitivity troponin I (hs-TnI).

  2. change of serum level of Myeloperoxidase (MPO).

    Time frame: 6 months

    Blood samples will be collected at baseline, after 3 months and after 6 months to evaluate Myeloperoxidase (MPO).

  3. change of serum level of Interleukin-6 (IL-6). > Liver function test (ALT).

    Time frame: 6 months

    Blood samples will be collected at baseline, after 3 months and after 6 months to evaluate Interleukin-6 (IL-6).

  4. change of serum level of Liver function test (ALT).

    Time frame: 6 months

    Blood samples will be collected at baseline, after 3 months and after 6 months to evaluate Liver function test (ALT).

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 21, 2022
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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