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Efficacy of Statin Addition to Neoadjuvant Chemotherapy Protocols for Breast Cancer

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ClinicalTrials.gov Identifier: NCT04705909
Recruitment Status : Not yet recruiting
First Posted : January 12, 2021
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
Omar Hamdy, Mansoura University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Pitavastatin Drug: placebo Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy of Statin Addition to Neoadjuvant Chemotherapy Protocols for Breast Cancer
Estimated Study Start Date : January 15, 2021
Estimated Primary Completion Date : September 15, 2021
Estimated Study Completion Date : December 15, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. The change in Cyclin D1 (candidate marker associated with breast tumor proliferation) [ Time Frame: Baseline up to 6 months ]
  2. The change in Cleaved caspase-3 (CC3) (candidate marker associated with tumor apoptosis) [ Time Frame: Baseline up to 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04705909


Contacts
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Contact: Samar A Dewidar, bachelor 01558333468 ext 002 s.dewidar@mans.edu.eg
Contact: Omar H Abdelaleem, PHD 01003526752 ext 002 omarhamdy87@gmail.com

Locations
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Egypt
Faculty of pharmacy, Mansoura university
Mansoura, Egypt, 35516
Contact: Amal M. Elgayar, professor    01005157096 ext 002    elgayaramal@gmail.com   
Principal Investigator: Amal M. Elgayar, Professor         
Sub-Investigator: Ahmed El tantawy, PHD         
Sub-Investigator: Moetaza M. Soliman, PHD         
Sponsors and Collaborators
Mansoura University
More Information
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Responsible Party: Omar Hamdy, Lecturer of Surgical oncology, Principal Investigator, Surgery department., Mansoura University
ClinicalTrials.gov Identifier: NCT04705909    
Other Study ID Numbers: 2020 - 176
First Posted: January 12, 2021    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pitavastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
 Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents