Possible Protective Effect of Rosuvastatin in Chemotherapy-induced Cardiotoxicity in HER2 Positive Breast Cancer Patients
Primary Purpose
Chemotherapy-induced Cardiotoxicity, Breast Cancer
Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Rosuvastatin 20mg
Sponsored by
About this trial
This is an interventional prevention trial for Chemotherapy-induced Cardiotoxicity
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.
Sites / Locations
- The Department of Clinical Oncology, Tanta University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
control-group
rosuvastatin-group
Arm Description
This group will include 25 patients who will receive doxorubicin for 4 cycles (3 months) followed by trastuzumab adjuvant therapy.
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).
Outcomes
Primary Outcome Measures
change in left ventricular ejection fraction(LVEF) detected by electrocardiography transthoracic echocardiography
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
change of serum level of High sensitivity troponin I (hs-TnI).
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).
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).
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).
Blood samples will be collected at baseline, after 3 months and after 6 months to evaluate Liver function test (ALT).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05338723
Brief Title
Possible Protective Effect of Rosuvastatin in Chemotherapy-induced Cardiotoxicity in HER2 Positive Breast Cancer Patients
Official Title
Possible Protective Effect of Rosuvastatin in Chemotherapy-induced Cardiotoxicity in HER2 Positive Breast Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
September 15, 2023 (Anticipated)
Study Completion Date
September 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Cardiotoxicity, Breast Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control-group
Arm Type
No Intervention
Arm Description
This group will include 25 patients who will receive doxorubicin for 4 cycles (3 months) followed by trastuzumab adjuvant therapy.
Arm Title
rosuvastatin-group
Arm Type
Active Comparator
Arm 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).
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin 20mg
Intervention Description
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 Measure Information:
Title
change in left ventricular ejection fraction(LVEF) detected by electrocardiography transthoracic echocardiography
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
change of serum level of High sensitivity troponin I (hs-TnI).
Description
Blood samples will be collected at baseline, after 3 months and after 6 months to evaluate High sensitivity troponin I (hs-TnI).
Time Frame
6 months
Title
change of serum level of Myeloperoxidase (MPO).
Description
Blood samples will be collected at baseline, after 3 months and after 6 months to evaluate Myeloperoxidase (MPO).
Time Frame
6 months
Title
change of serum level of Interleukin-6 (IL-6). > Liver function test (ALT).
Description
Blood samples will be collected at baseline, after 3 months and after 6 months to evaluate Interleukin-6 (IL-6).
Time Frame
6 months
Title
change of serum level of Liver function test (ALT).
Description
Blood samples will be collected at baseline, after 3 months and after 6 months to evaluate Liver function test (ALT).
Time Frame
6 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
only female patients are included in the study
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
khlood mohamed kettana
Phone
01091100037
Email
khlood.kettana@pharm.tanta.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
khlood m. kettana
Organizational Affiliation
Tanta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Department of Clinical Oncology, Tanta University Hospital
City
Tanta
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
khlood mohamed kettana
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Possible Protective Effect of Rosuvastatin in Chemotherapy-induced Cardiotoxicity in HER2 Positive Breast Cancer Patients
We'll reach out to this number within 24 hrs