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Study of the Therapeutic Effect of Atorvastatin on the Clinical Outcomes in HER2 Negative Breast Cancer Patients"

Primary Purpose

Breast Cancer

Status

Recruiting

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Atorvastatin 80mg

placebo

About this trial

This is an interventional prevention trial for Breast Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Confirmed breast cancer any stage confirmed by radiological and pathological or by clinical evaluation undergo surgery or receiving neo/adjuvant chemotherapy treatment
Age above 18 years
HER2 negative core biopsy
Adequate renal function: the calculated creatinine clearance should be ≥50 mL/min
Patients must be accessible for treatment and follow-up
Performance status of Eastern Cooperative Oncology Group (ECOG) ≤ 2

Exclusion Criteria:

Known hypersensitivity reaction to the investigational compounds or incorporated substances
patients who are unlikely to comply with trial requirements (eg, confusion, psychological or mood disturbances ,alcoholism, cardiac arrhythmia)

Sites / Locations

Beni-Suef university hospitalRecruiting
Fayoum Oncology Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

study

control group

Arm Description

breast cancer patient received Atorvastatin 80 mg

breast cancer patient received placebo

Outcomes

Primary Outcome Measures

Ki-67 molecular

antiproliferative effect Ki-67 molecular gene expression

TAZ (WWTR1) TAZ expression

cell proliferative ability via TAZ (WWTR1) TAZ expression

cardiac markers

protective effect of atorvastatin for Anthracycline induced cardiotoxicity

Secondary Outcome Measures

Overall survival OS

The length of time from r the start of treatment for a disease and are still alive

Overall response rate

the proportion of patients who have a partial or complete response to therapy

Full Information

NCT ID

NCT05103644

First Posted

October 21, 2021

Last Updated

October 31, 2022

Sponsor

Beni-Suef University

1. Study Identification

Unique Protocol Identification Number

NCT05103644

Brief Title

Study of the Therapeutic Effect of Atorvastatin on the Clinical Outcomes in HER2 Negative Breast Cancer Patients"

Official Title

Study of the Therapeutic Effect of Atorvastatin on the Clinical Outcomes in HER2 Negative Breast Cancer Patients"

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 30, 2021 (Actual)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beni-Suef University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Statins, a major class of drugs for treatment of hypercholesterolemia, are widely used due to a notable prevention of cardiovascular disease, and accumulating evidence proposes a promising role of statins in breast cancer

Detailed Description

Statin has lipid independent effects include inhibition of inflammatory responses, immunomodulatory actions, apoptotic and antiproliferative effects, which might contribute to the suggested anti-tumoral effects of these agents. The epidemiological evidence projecting statins as anticancer agents is variable, depending on the particular type of cancer in question as well as the class of statin used

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Model Description

study group control group

Masking

Participant

Masking Description

single blind

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

study

Arm Type

Experimental

Arm Description

breast cancer patient received Atorvastatin 80 mg

Arm Title

control group

Arm Type

Placebo Comparator

Arm Description

breast cancer patient received placebo

Intervention Type

Drug

Intervention Name(s)

Atorvastatin 80mg

Other Intervention Name(s)

ATOR

Intervention Description

patients received statin experimental group

Intervention Type

Other

Intervention Name(s)

placebo

Other Intervention Name(s)

placebo single blind

Intervention Description

patients received placebo control group

Primary Outcome Measure Information:

Title

Ki-67 molecular

Description

antiproliferative effect Ki-67 molecular gene expression

Time Frame

3 month

Title

TAZ (WWTR1) TAZ expression

Description

cell proliferative ability via TAZ (WWTR1) TAZ expression

Time Frame

3 months

Title

cardiac markers

Description

protective effect of atorvastatin for Anthracycline induced cardiotoxicity

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Overall survival OS

Description

The length of time from r the start of treatment for a disease and are still alive

Time Frame

time frame 6 month

Title

Overall response rate

Description

the proportion of patients who have a partial or complete response to therapy

Time Frame

6 months

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Femal breast cancer

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Confirmed breast cancer any stage confirmed by radiological and pathological or by clinical evaluation undergo surgery or receiving neo/adjuvant chemotherapy treatment Age above 18 years HER2 negative core biopsy Adequate renal function: the calculated creatinine clearance should be ≥50 mL/min Patients must be accessible for treatment and follow-up Performance status of Eastern Cooperative Oncology Group (ECOG) ≤ 2 Exclusion Criteria: Known hypersensitivity reaction to the investigational compounds or incorporated substances patients who are unlikely to comply with trial requirements (eg, confusion, psychological or mood disturbances ,alcoholism, cardiac arrhythmia)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

ALshaimaa Ibrahim Rabie, Msc

Phone

01061263030

alshaimaa.ph@o6u.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Raghda RS Hussein, PHD

Raghda.hussien@phram.bsu.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed Hassan shaaban, MD

Organizational Affiliation

Beni-Suef University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Raghda RS Hussein, PHD

Organizational Affiliation

Beni-Suef University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Reham shehab El-Nemr, MD

Organizational Affiliation

Fayoum University

Official's Role

Study Director

Facility Information:

Facility Name

Beni-Suef university hospital

City

Banī Suwayf

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ahmed Hasssan Shaaban, MD

Facility Name

Fayoum Oncology Center

City

Fayoum

Country

Egypt

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alshaimaa Ibrahim, Rabie

alshaimaa.ph@o6u.edu.eg

12. IPD Sharing Statement

Learn more about this trial

Study of the Therapeutic Effect of Atorvastatin on the Clinical Outcomes in HER2 Negative Breast Cancer Patients"

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