A Phase 2 Randomized, Double-blind Trial Evaluating the Effects of Chloroquine in Breast Cancer

• Status: Unknown status
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Hospital Research Institute
• Treatments: Chloroquine; Chloroquine diphosphate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.