Efficacy of Statin Addition to Neoadjuvant Chemotherapy Protocols for Breast Cancer

NCT04705909 | Unknown Phase 2

• 1 other identifier: 2020 - 176
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  6 months

• 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.

  6 months

Secondary Outcomes (2)

• The change in Cyclin D1 (candidate marker associated with breast tumor proliferation)

  Baseline up to 6 months

• The change in Cleaved caspase-3 (CC3) (candidate marker associated with tumor apoptosis)

  Baseline up to 6 months

Study Arms (2)

Pitavastatin group

EXPERIMENTAL

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

Drug: Pitavastatin

Placebo group

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

Pitavastatin DRUG

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.

Also known as: HMG CoA reductase inhibitor " Lipovastatin"

Pitavastatin group

placebo DRUG

patients in this group will receive placebo tablets concomitantly with the intended chemotherapy for the treatment period prior to surgery.

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of pharmacy, Mansoura university

Al Mansurah, 35516, Egypt

Location

Related Publications (1)

• 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.

  PMID: 36387337 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pitavastatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Samar A Dewidar, bachelor

CONTACT

01558333468; s.dewidar@mans.edu.eg

Omar H Abdelaleem, PHD

CONTACT

01003526752; omarhamdy87@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Surgical oncology, Principal Investigator, Surgery department.

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 12, 2021
• Study Start: January 15, 2021
• Primary Completion: September 15, 2021
• Study Completion: December 15, 2021
• Last Updated: January 12, 2021

Record last verified: 2021-01

Locations

EG (1)