Efficacy of Statin Addition to Neoadjuvant Chemotherapy Protocols for Breast Cancer

Phase 2/3 Unknown 60 enrolled Mansoura University

RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start: 2021-01-15
Primary completion: 2021-09-15
Completion: 2021-12-15

Outcome

Mixed primary results

paper reductions in tumor size [-19.8 (-41.5, 9.5)] compared to those in the control group [-5.0 (-15.5, 0.0), p = 0.0009]. PMID 36387337 ↗

paper The change in Ki67 from baseline to the end of therapy was similar between the two groups (p = 0.12). PMID 36387337 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pitavastatin	Small molecule	2 mg	Oral