Efficacy of Statin Addition to Neoadjuvant Chemotherapy Protocols for Breast Cancer

Mansoura University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Breast Cancer

Treatments: Drug: placebo; Drug: Pitavastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT04705909

2020 - 176

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Pitavastatin group

Experimental group

Description:

For the intended neoadjuvant treatment period, participants will receive -in addition to standard chemotherapy protocol - Pitavastatin tablets 2 mg once daily.

Treatment:

Drug: Pitavastatin

Placebo group

Placebo Comparator group

Description:

For the intended neoadjuvant treatment period, participants will receive -in addition to standard chemotherapy protocol - Placebo tablets matching pitavastatin orally once daily.

Treatment:

Drug: placebo