NCT05338723

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2020

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2020

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

3 years

First QC Date

April 4, 2022

Last Update Submit

February 27, 2024

Conditions

Chemotherapy-induced CardiotoxicityBreast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Secondary Outcomes (4)

  • change of serum level of High sensitivity troponin I (hs-TnI).

    6 months

  • change of serum level of Myeloperoxidase (MPO).

    6 months

  • change of serum level of Interleukin-6 (IL-6). > Liver function test (ALT).

    6 months

  • change of serum level of Liver function test (ALT).

    6 months

Study Arms (2)

control-group

NO INTERVENTION

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

rosuvastatin-group

ACTIVE COMPARATOR

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).

Drug: Rosuvastatin 20mg

Interventions

Rosuvastatin 20mgDRUG

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).

rosuvastatin-group

Eligibility Criteria

Age25 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsonly female patients are included in the study
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Department of Clinical Oncology, Tanta University Hospital

Tanta, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • khlood m. kettana

    Tanta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
demonstrator at clinical pharmacy department,faculty of pharmacy

Study Record Dates

First Submitted

April 4, 2022

First Posted

April 21, 2022

Study Start

September 15, 2020

Primary Completion

September 15, 2023

Study Completion

September 15, 2023

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)