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

Tanta University

Status and phase: Completed; Phase 3

Conditions: Breast Cancer; Chemotherapy-induced Cardiotoxicity

Treatments: Drug: Rosuvastatin 20mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05338723

rosuva2020

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: Female

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

control-group

No Intervention group

Description:

This group will include 25 patients who will receive doxorubicin for 4 cycles (3 months) followed by trastuzumab adjuvant therapy.

rosuvastatin-group

Active Comparator group

Description:

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).

Treatment:

Drug: Rosuvastatin 20mg