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

NCT02333890 | Unknown Phase 2 DMC

• 1 other identifier: OTT 14-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

breast

Outcome Measures

Primary Outcomes (1)

• Effect of a brief course of CQ on tumour proliferation and apoptosis

  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.

  baseline and at 2-6 weeks, the day of surgery

Secondary Outcomes (2)

• 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

Other Outcomes (2)

• Assessment of Toxicity of CQ in Breast Cancer Patients

  baseline and at 2-6 weeks, the day of surgery

• Differential Gene and Expression using Microarray Analysis.

  baseline and at 2-6 weeks, the day of surgery

Study Arms (2)

Chloroquine

EXPERIMENTAL

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.

Drug: Chloroquine

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Chloroquine DRUG

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

Chloroquine

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital Woman's Breast Health Centre

Ottawa, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Chloroquine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Angel Arnaout, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angel Arnaout, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2015
• First Posted: January 7, 2015
• Study Start: July 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2018
• Last Updated: November 18, 2016

Record last verified: 2016-11

Locations

CA (1)