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

Last updated: November 17, 2016
Sponsor: Ottawa Hospital Research Institute
Overall Status: Trial Status Unknown

Phase

2

Condition

Breast Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT02333890
OTT 14-02
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • newly diagnosed histologically confirmed primary invasive breast cancer who iscurrently 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

Exclusion Criteria:

  • Known Metastatic breast cancer

  • history of pre-existing known retinal or ocular pathology patient has only onefunctioning 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 otherconditions

  • 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 psychoticstates)

  • current known pregnancy or actively nursing

  • allergic reactions to quinolones or CQ

  • inability to consent.

Study Design

Total Participants: 60
Study Start date:
July 01, 2015
Estimated Completion Date:
March 31, 2018

Study Description

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.

Connect with a study center

  • The Ottawa Hospital Woman's Breast Health Centre

    Ottawa, Ontario
    Canada

    Active - Recruiting

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