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Efficacy of Statin Addition to Neoadjuvant Chemotherapy Protocols for Breast Cancer

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Pitavastatin
placebo
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

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

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

Sites / Locations

  • Faculty of pharmacy, Mansoura university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pitavastatin group

Placebo group

Arm Description

For the intended neoadjuvant treatment period, participants will receive -in addition to standard chemotherapy protocol - Pitavastatin tablets 2 mg once daily.

For the intended neoadjuvant treatment period, participants will receive -in addition to standard chemotherapy protocol - Placebo tablets matching pitavastatin orally once daily.

Outcomes

Primary Outcome Measures

clinical response rate
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.
Relative reduction of Ki67 in tumor samples
It will be described as average pre-post differences in percent positive cells with 95% Wilson confidence intervals.

Secondary Outcome Measures

The change in Cyclin D1 (candidate marker associated with breast tumor proliferation)
The change in Cleaved caspase-3 (CC3) (candidate marker associated with tumor apoptosis)

Full Information

First Posted
January 4, 2021
Last Updated
January 9, 2021
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT04705909
Brief Title
Efficacy of Statin Addition to Neoadjuvant Chemotherapy Protocols for Breast Cancer
Official Title
Efficacy of Statin Addition to Neoadjuvant Chemotherapy Protocols for Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2021 (Anticipated)
Primary Completion Date
September 15, 2021 (Anticipated)
Study Completion Date
December 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

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
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pitavastatin group
Arm Type
Experimental
Arm Description
For the intended neoadjuvant treatment period, participants will receive -in addition to standard chemotherapy protocol - Pitavastatin tablets 2 mg once daily.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
For the intended neoadjuvant treatment period, participants will receive -in addition to standard chemotherapy protocol - Placebo tablets matching pitavastatin orally once daily.
Intervention Type
Drug
Intervention Name(s)
Pitavastatin
Other Intervention Name(s)
HMG CoA reductase inhibitor " Lipovastatin"
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
patients in this group will receive placebo tablets concomitantly with the intended chemotherapy for the treatment period prior to surgery.
Primary Outcome Measure Information:
Title
clinical response rate
Description
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.
Time Frame
6 months
Title
Relative reduction of Ki67 in tumor samples
Description
It will be described as average pre-post differences in percent positive cells with 95% Wilson confidence intervals.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The change in Cyclin D1 (candidate marker associated with breast tumor proliferation)
Time Frame
Baseline up to 6 months
Title
The change in Cleaved caspase-3 (CC3) (candidate marker associated with tumor apoptosis)
Time Frame
Baseline up to 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samar A Dewidar, bachelor
Phone
01558333468
Ext
002
Email
s.dewidar@mans.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Omar H Abdelaleem, PHD
Phone
01003526752
Ext
002
Email
omarhamdy87@gmail.com
Facility Information:
Facility Name
Faculty of pharmacy, Mansoura university
City
Mansoura
ZIP/Postal Code
35516
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amal M. Elgayar, professor
Phone
01005157096
Ext
002
Email
elgayaramal@gmail.com
First Name & Middle Initial & Last Name & Degree
Amal M. Elgayar, Professor
First Name & Middle Initial & Last Name & Degree
Ahmed El tantawy, PHD
First Name & Middle Initial & Last Name & Degree
Moetaza M. Soliman, PHD

12. IPD Sharing Statement

Citations:
PubMed Identifier
36387337
Citation
Dewidar SA, Hamdy O, Eltantawy A, El-Mesery M, El Gayar AM, Soliman MM. Effect of concomitant use of pitavastatin with neoadjuvant chemotherapy protocols in breast cancer patients: A randomized controlled clinical trial. Saudi Pharm J. 2022 Oct;30(10):1486-1496. doi: 10.1016/j.jsps.2022.07.011. Epub 2022 Jul 25.
Results Reference
derived

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Efficacy of Statin Addition to Neoadjuvant Chemotherapy Protocols for Breast Cancer

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