Recruiting
Phase 2

Chloroquine

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT02333890

Conditions

Breast Cancer

Invasive Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Chloroquine

Placebo

Study Details

Brief 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.

Conditions

Breast Cancer

Invasive Breast Cancer

Study ID

NCT02333890

Start date

Jul, 2015

Status verified date

Nov, 2016

Completion date

Mar, 2018

Anticipated

Primary completion date

Mar, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

placebo comparator: 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.

Interventions

Chloroquine

chloroquine 500 mg daily as an oral capsule during the wait time to surgery.

Placebo

Primary outcome measure

  • Effect of a brief course of CQ on tumour proliferation and apoptosis [ Time Frame: baseline and at 2-6 weeks, the day of surgery ]

Central Contacts and Locations

Central contacts

Angel Arnaout, MD

613-798-5555anarnaout@toh.on.ca

Locations

The Ottawa Hospital Woman's Breast Health Centre

Recruiting

Ottawa, Ontario, Canada

Contacts

Angel Arnaout, Dr.

613-798-5555

Principal Investigator:

Angel Arnaout, Dr.

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Nov 18, 2016

Last verified

Nov, 2016

Keywords

  • breast

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2016-11-18.