A Phase 2 Randomized, Double-blind, Window of Opportunity Trial Evaluating Clinical and Correlative Effects of Chloroquine as a Novel Therapeutic Strategy in Breast Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Effect of a brief course of CQ on tumour proliferation and apoptosis
研究概览
简要总结
Chloroquine (CQ) is a well known, well tolerated medication that has been used for many years traditionally for arthritis, lupus, and malaria. It has anti-inflammatory properties but is often the drug of choice for arthritis and malaria due to its few side effects. Recently, laboratory investigations have proven that CQ may potentially have anti-cancer properties, by inhibiting a process which allows cancers such as breast cancer to continue to grow (a process known as "autophagy"). Therefore, this study will look at how well CQ can inhibit the growth of breast cancers in patients while waiting for surgery.
详细描述
Patients diagnosed with breast cancer can sometimes wait up to 6 weeks for their surgery. The wait leading up to surgery is a potentially long and anxious time. Since no treatment is happening during this period anyway, this study will allow patients to receive CQ during this waiting period. This study will compare CQ treatment before surgery with the standard approach during this time, which is no treatment.
Although CQ is widely used for the treatment of arthritis and malaria, CQ is considered investigational for use in breast cancer.
The study will NOT interfere with the routine assessments as part of the pre-operative care, NOR will it delay the date of surgery.
This study compares the effects of the CQ to placebo. Participants will be randomized 1:1 and be provided with the blinded placebo or QC (500mg daily) during the wait time. Biomarker testing will be performed on the initial biopsy tissue and at the time of surgery as well as blood work. There is also an opportunity for participants to enrol in the optional sample collection for future research.
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
- Triple (Participant, Care Provider, Investigator)
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
- •newly diagnosed histologically confirmed primary invasive breast cancer who is currently not undergoing any treatment while awaiting surgery in the next 2-6 weeks
- •tumour ≥ 1.5 cm by palpation or imaging
- •ECOG performance status 0-2
- •written informed consent for the study
排除标准
- •Known Metastatic breast cancer
- •history of pre-existing known retinal or ocular pathology patient has only one functioning eye
- •abnormal hepatic function (serum AST or ALT >3x upper limit of normal)
- •currently on CQ or HCQ or has been on the drug within the past 3 months for other conditions
- •known history of psoriasis
- •known history of epilepsy or seizures
- •electrocardiogram showing QT prolongation based on QTc interval >450 ms
- •inability to comply with a study protocol (abuse of alcohol, drugs or psychotic states)
- •current known pregnancy or actively nursing
- •allergic reactions to quinolones or CQ
- •inability to consent.
研究组 & 干预措施
Chloroquine
The daily oral dose per patient is 500 mg of chloroquine. Patients may be taking the drug for 2-6 weeks leading up to the date of the surgery. The last dose will be taken the evening before surgery.
干预措施: Chloroquine (Drug)
Placebo
The daily oral dose per patient is 500 mg of placebo (lactose). Patients may be taking the drug for 2-6 weeks leading up to the date of the surgery. The last dose will be taken the evening before surgery.
干预措施: Placebo (Drug)
结局指标
主要结局
Effect of a brief course of CQ on tumour proliferation and apoptosis
时间窗: baseline and at 2-6 weeks, the day of surgery
We will assess relative changes in proliferative and apoptotic response indices based on Ki67 and TUNEL assays in primary breast cancer biopsies pre- and post-treatment with CQ, as these changes occur more rapidly than gross changes in tumour volume.
次要结局
- Measure of Circulating CQ Metabolites(baseline and at 2-6 weeks, the day of surgery)
- Autophagic Markers in Cancerous and Stromal Tissue(baseline and at 2-6 weeks, the day of surgery)