Efficacy of Statin Addition to Neoadjuvant Chemotherapy Protocols for Breast Cancer

Phase 2

• Conditions: Breast Cancer
• Interventions: Drug: placebo; Drug: Pitavastatin

• Registration Number: NCT04705909
• Lead Sponsor: Mansoura University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-04
• Study First Submitted QC: 2021-01-09
• Last Update Submitted: 2021-01-09
• Study First Posted: 2021-01-12
• Last Update Posted: 2021-01-12
• Study Start: 2021-01-15
• Primary Completion: 2021-09-15
• Study Completion: 2021-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	placebo	For the intended neoadjuvant treatment period, participants will receive -in addition to standard chemotherapy protocol - Placebo tablets matching pitavastatin orally once daily.
Pitavastatin group	Pitavastatin	For the intended neoadjuvant treatment period, participants will receive -in addition to standard chemotherapy protocol - Pitavastatin tablets 2 mg once daily.

Primary Outcome Measures

Name	Time	Method
clinical response rate	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.
Relative reduction of Ki67 in tumor samples	6 months	It will be described as average pre-post differences in percent positive cells with 95% Wilson confidence intervals.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of pharmacy, Mansoura university; 🇪🇬 Mansoura, Egypt