Clinical trial · Interventional
A Phase 2 Randomized, Double-blind Trial Evaluating the Effects of Chloroquine in Breast Cancer
A Phase 2 Randomized, Double-blind, Window of Opportunity Trial Evaluating Clinical and Correlative Effects of Chloroquine as a Novel Therapeutic Strategy in Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Invasive Breast Cancer | Invasive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chloroquine | Drug | Chloroquine | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Chloroquine
- description
- 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.
- interventionNames
- Drug: Chloroquine
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 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.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Effect of a brief course of CQ on tumour proliferation and apoptosis
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available