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

• Status: Recruiting
• Trial end date: 2023-09-15
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tanta University
• Treatments: Rosuvastatin Calcium

Criteria

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.