Clinical trial NCT04705909: Efficacy of Statin Addition to Neoadjuvant Chemotherapy Protocols for Breast Cancer
Official title: Efficacy of Statin Addition to Neoadjuvant Chemotherapy Protocols for Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Breast Cancer
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: clinical response rate
timeFrame: 6 months
measure: Relative reduction of Ki67 in tumor samples
timeFrame: 6 months
Secondary outcomes:
measure: The change in Cyclin D1 (candidate marker associated with breast tumor proliferation)
timeFrame: Baseline up to 6 months
measure: The change in Cleaved caspase-3 (CC3) (candidate marker associated with tumor apoptosis)
timeFrame: Baseline up to 6 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of pharmacy, Mansoura university
Study officials:
References:
citation: 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.