Efficacy of Statin Addition to Neoadjuvant Chemotherapy Protocols for Breast Cancer

Breast Cancer Clinical Trial

Official title:

Efficacy of Statin Addition to Neoadjuvant Chemotherapy Protocols for Breast Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04705909
• Other study ID #: 2020 - 176
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: January 15, 2021
• Est. completion date: December 15, 2021

Study information

• Verified date: January 2021
• Source: Mansoura University
• Contact: Samar A Dewidar, bachelor
• Phone: 01558333468
• Email: s.dewidar[@]mans.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 15, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of pharmacy, Mansoura university	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	The change in Cyclin D1 (candidate marker associated with breast tumor proliferation)		Baseline up to 6 months
Secondary	The change in Cleaved caspase-3 (CC3) (candidate marker associated with tumor apoptosis)		Baseline up to 6 months