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

NCT ID: NCT05338723

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-15
• Study Completion Date: 2023-09-15

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.

Conditions

Chemotherapy-induced Cardiotoxicity; Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

control-group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

rosuvastatin-group

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).

Group Type: ACTIVE_COMPARATOR

Rosuvastatin 20mg

Intervention Type: 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).

Interventions

Rosuvastatin 20mg

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).

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Khlood Mohamed Kettana

demonstrator at clinical pharmacy department,faculty of pharmacy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

khlood m. kettana

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Locations

The Department of Clinical Oncology, Tanta University Hospital

Tanta, , Egypt

Countries

Egypt

Other Identifiers

rosuva2020

Identifier Type: -

Identifier Source: org_study_id