Efficacy of Statin Addition to Neoadjuvant Chemotherapy Protocols for Breast Cancer

January 9, 2021 updated by: Omar Hamdy, Mansoura University

Different modalities for breast cancer treatments have exhausting and distressing side effects and toxicities leading to decreased compliance. Thus, repurposing drugs with accepted safety profile and possible antitumor activity becomes an eminent constraint.

Statins have been reported to have possible advantages as anticancer, and control of cancer progression. Moreover, they can sensitize cancer cells for radiotherapy. Therefore, the investigators aim to investigate the effect of (pitavastatin) added to conventional chemotherapy protocols for breast cancer patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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
      • Mansoura, Egypt, 35516
        • Faculty of pharmacy, Mansoura university
        • Contact:
        • Principal Investigator:
          • Amal M. Elgayar, Professor
        • Sub-Investigator:
          • Ahmed El tantawy, PHD
        • Sub-Investigator:
          • Moetaza M. Soliman, PHD

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Provision of informed consent before any study-specific procedures.
  • Histologic confirmation of invasive breast cancer.
  • Plans for the administration of neoadjuvant chemotherapy.
  • Not currently pregnant during the study

Exclusion Criteria:

  • Severe gastrointestinal disorder
  • Current use of statins or fibrates for any time during the 3 months before the study
  • Proven hypersensitivity to statins
  • Currently on medication for hypercholesterolemia
  • Strong Cytochrome P450 3A4 (abbreviated CYP3A4) (e.g., clarithromycin, HIV protease inhibitors, and itraconazole), given potential interactions with statins
  • Renal impairment with a creatinine > 1.4 mg/dl
  • Hepatic impairment: Aspartate transaminase (AST)/(SGOT), Alanine Transaminase (ALT)/(SGPT) ≥ 2.5 x upper limit of the normal range (ULN), OR Total bilirubin ≥ 1.5 x ULN (subjects with Gilbert's syndrome can have bilirubin of up to 1.5 x ULN), OR Alkaline phosphatase > 2.5 x ULN
  • Central nervous system (CNS) diseases and major psychiatric diseases or inability to comply with the protocol procedures
  • Active infections
  • Cardiac failure, class I-IV
  • Current anticoagulant or antiplatelet aggregation therapy
  • Current lactation

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pitavastatin group
For the intended neoadjuvant treatment period, participants will receive -in addition to standard chemotherapy protocol - Pitavastatin tablets 2 mg once daily.
Drug: Pitavastatin
Pitavastatin 2 mg oral tablets daily will be given to the patients concomitantly with the intended chemotherapy protocol for the treatment period prior to surgery.
Other Names:
  • HMG CoA reductase inhibitor " Lipovastatin"
Placebo Comparator: Placebo group
For the intended neoadjuvant treatment period, participants will receive -in addition to standard chemotherapy protocol - Placebo tablets matching pitavastatin orally once daily.
Drug: placebo
patients in this group will receive placebo tablets concomitantly with the intended chemotherapy for the treatment period prior to surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical response rate
Time Frame: 6 months
Response to preoperative therapy as per ultrasonographic tumor size assessment. A responder will have > 50% decrease in the size of the primary tumor without appearance of new lesions.
6 months
Relative reduction of Ki67 in tumor samples
Time Frame: 6 months
It will be described as average pre-post differences in percent positive cells with 95% Wilson confidence intervals.
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The change in Cyclin D1 (candidate marker associated with breast tumor proliferation)
Time Frame: Baseline up to 6 months
Baseline up to 6 months
The change in Cleaved caspase-3 (CC3) (candidate marker associated with tumor apoptosis)
Time Frame: Baseline up to 6 months
Baseline up to 6 months

Collaborators and Investigators

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

Sponsor

Mansoura University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

January 15, 2021

Primary Completion (Anticipated)

September 15, 2021

Study Completion (Anticipated)

December 15, 2021

Study Registration Dates

First Submitted

January 4, 2021

First Submitted That Met QC Criteria

January 9, 2021

First Posted (Actual)

January 12, 2021

Study Record Updates

Last Update Posted (Actual)

January 12, 2021

Last Update Submitted That Met QC Criteria

January 9, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020 - 176

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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