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

Sponsor
Beni-Suef University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05103644
Collaborator
Fayoum oncology Center (Other)
60
Enrollment
2
Locations
2
Arms
14
Anticipated Duration (Months)
30
Patients Per Site
2.1
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Atorvastatin 80mg
  • Other: placebo
 Phase 2/Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
study group control groupstudy group control group
Masking:
Single (Participant)
Masking Description:
single blind
Primary Purpose:
Prevention
Official Title:
Study of the Therapeutic Effect of Atorvastatin on the Clinical Outcomes in HER2 Negative Breast Cancer Patients"
Actual Study Start Date :
Oct 30, 2021
Anticipated Primary Completion Date :
Jul 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Ki-67 molecular [3 month]

      antiproliferative effect Ki-67 molecular gene expression

    2. TAZ (WWTR1) TAZ expression [3 months]

      cell proliferative ability via TAZ (WWTR1) TAZ expression

    3. cardiac markers [3 months]

      protective effect of atorvastatin for Anthracycline induced cardiotoxicity

    Secondary Outcome Measures

    1. Overall survival OS [time frame 6 month]

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

    2. Overall response rate [6 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beni-Suef university hospital Banī Suwayf Egypt
    2 Fayoum Oncology Center Fayoum Egypt

    Sponsors and Collaborators

    • Beni-Suef University
    • Fayoum oncology Center

    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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ALshaimaa Ibrahim Rabie, clinical pharmacist Msc, Pharm D, Beni-Suef University
    ClinicalTrials.gov Identifier:
    NCT05103644
    Other Study ID Numbers:
    • FMBSUREC/10102021/Rabie
    First Posted:
    Nov 2, 2021
    Last Update Posted:
    Dec 8, 2021
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms
    Atorvastatin

    Study Results

    No Results Posted as of Dec 8, 2021