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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

About this trial

This is an interventional prevention trial for Chemotherapy-induced Cardiotoxicity

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept 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.

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

NCT ID

NCT05338723

First Posted

April 4, 2022

Last Updated

June 12, 2023

Sponsor

Tanta University

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

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

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

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

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

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

Learn more about this trial

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

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