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

October 31, 2022 updated by: ALshaimaa Ibrahim Rabie, Beni-Suef University
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Banī Suwayf, Egypt
        • Recruiting
        • Beni-Suef University hospital
        • Contact:
          • Ahmed Hasssan Shaaban, MD
      • Fayoum, Egypt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: study
breast cancer patient received Atorvastatin 80 mg
Drug: Atorvastatin 80mg
patients received statin experimental group
Other Names:
  • ATOR
PLACEBO_COMPARATOR: control group
breast cancer patient received placebo
Other: placebo
patients received placebo control group
Other Names:
  • placebo single blind

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ki-67 molecular
Time Frame: 3 month
antiproliferative effect Ki-67 molecular gene expression
3 month
TAZ (WWTR1) TAZ expression
Time Frame: 3 months
cell proliferative ability via TAZ (WWTR1) TAZ expression
3 months
cardiac markers
Time Frame: 3 months
protective effect of atorvastatin for Anthracycline induced cardiotoxicity
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival OS
Time Frame: time frame 6 month
The length of time from r the start of treatment for a disease and are still alive
time frame 6 month
Overall response rate
Time Frame: 6 months
the proportion of patients who have a partial or complete response to therapy
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Investigators

  • Study Director: Ahmed Hassan shaaban, MD, Beni-Suef University
  • Study Director: Raghda RS Hussein, PHD, Beni-Suef University
  • Study Director: Reham shehab El-Nemr, MD, Fayoum University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 30, 2021

Primary Completion (ANTICIPATED)

December 30, 2023

Study Completion (ANTICIPATED)

December 30, 2024

Study Registration Dates

First Submitted

October 21, 2021

First Submitted That Met QC Criteria

October 21, 2021

First Posted (ACTUAL)

November 2, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 2, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMBSUREC/10102021/Rabie

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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