Efficacy of Statin Addition to Neoadjuvant Chemotherapy Protocols for Breast Cancer
NCT ID: NCT04705909
Last Updated: 2021-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
60 participants
INTERVENTIONAL
2021-01-15
2021-12-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Pitavastatin group
For the intended neoadjuvant treatment period, participants will receive -in addition to standard chemotherapy protocol - Pitavastatin tablets 2 mg once daily.
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 group
For the intended neoadjuvant treatment period, participants will receive -in addition to standard chemotherapy protocol - Placebo tablets matching pitavastatin orally once daily.
placebo
patients in this group will receive placebo tablets concomitantly with the intended chemotherapy for the treatment period prior to surgery.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologic confirmation of invasive breast cancer.
* Plans for the administration of neoadjuvant chemotherapy.
* Not currently pregnant during the study
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Omar Hamdy
Lecturer of Surgical oncology, Principal Investigator, Surgery department.
Locations
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Faculty of pharmacy, Mansoura university
Al Mansurah, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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2020 - 176
Identifier Type: -
Identifier Source: org_study_id
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