Status:
UNKNOWN
Efficacy of Statin Addition to Neoadjuvant Chemotherapy Protocols for Breast Cancer
Lead Sponsor:
Mansoura University
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04705909
Start Date
January 15 2021
End Date
December 15 2021
Last Update
January 12 2021
Active Locations (1)
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1
Faculty of pharmacy, Mansoura university
Al Mansurah, Egypt, 35516