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

Phase 3

Completed

• Conditions: Breast Cancer; Chemotherapy-induced Cardiotoxicity
• Interventions: Drug: Rosuvastatin 20mg

• Registration Number: NCT05338723
• Lead Sponsor: Tanta University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-09-15
• Study First Submitted: 2022-04-04
• Study First Submitted QC: 2022-04-18
• Study First Posted: 2022-04-21
• Primary Completion: 2023-09-15
• Study Completion: 2023-09-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rosuvastatin-group	Rosuvastatin 20mg	This group will include 25 patients who will receive doxorubicin for 4 cycles (3 months) followed by trastuzumab adjuvant therapy in addition to 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 Outcome Measures

Name	Time	Method
change in left ventricular ejection fraction(LVEF) detected by electrocardiography transthoracic echocardiography	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 Outcome Measures

Name	Time	Method
change of serum level of High sensitivity troponin I (hs-TnI).	6 months	Blood samples will be collected at baseline, after 3 months and after 6 months to evaluate High sensitivity troponin I (hs-TnI).
change of serum level of Myeloperoxidase (MPO).	6 months	Blood samples will be collected at baseline, after 3 months and after 6 months to evaluate Myeloperoxidase (MPO).
change of serum level of Interleukin-6 (IL-6). > Liver function test (ALT).	6 months	Blood samples will be collected at baseline, after 3 months and after 6 months to evaluate Interleukin-6 (IL-6).
change of serum level of Liver function test (ALT).	6 months	Blood samples will be collected at baseline, after 3 months and after 6 months to evaluate Liver function test (ALT).

Trial Locations

Locations (1)

The Department of Clinical Oncology, Tanta University Hospital; 🇪🇬 Tanta, Egypt