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

NCT ID: NCT02333890

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2018-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer Invasive Breast Cancer

Keywords

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breast

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Chloroquine

Intervention Type DRUG

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

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Chloroquine

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

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ottawa Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Angel Arnaout, MD

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital

Locations

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The Ottawa Hospital Woman's Breast Health Centre

Ottawa, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Angel Arnaout, MD

Role: CONTACT

Phone: 613-798-5555

Email: [email protected]

Facility Contacts

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Angel Arnaout, Dr.

Role: primary

Other Identifiers

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OTT 14-02

Identifier Type: -

Identifier Source: org_study_id