Efficacy of Statin Addition to Neoadjuvant Chemotherapy Protocols for Breast Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- clinical response rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Pitavastatin group
For the intended neoadjuvant treatment period, participants will receive -in addition to standard chemotherapy protocol - Pitavastatin tablets 2 mg once daily.
干预措施: Pitavastatin (Drug)
Placebo group
For the intended neoadjuvant treatment period, participants will receive -in addition to standard chemotherapy protocol - Placebo tablets matching pitavastatin orally once daily.
干预措施: placebo (Drug)
结局指标
主要结局
clinical response rate
时间窗: 6 months
Response to preoperative therapy as per ultrasonographic tumor size assessment. A responder will have \> 50% decrease in the size of the primary tumor without appearance of new lesions.
Relative reduction of Ki67 in tumor samples
时间窗: 6 months
It will be described as average pre-post differences in percent positive cells with 95% Wilson confidence intervals.
次要结局
- The change in Cyclin D1 (candidate marker associated with breast tumor proliferation)(Baseline up to 6 months)
- The change in Cleaved caspase-3 (CC3) (candidate marker associated with tumor apoptosis)(Baseline up to 6 months)
研究者
Omar Hamdy
Lecturer of Surgical oncology, Principal Investigator, Surgery department.
Mansoura University