Overview

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.