Clinical trial · Interventional
Autophagy Inhibition Using Hydrochloroquine in Breast Cancer Patients
Autophagy Inhibition Using Hydrochloroquine in Breast Cancer Patients:a Pilot Study
- 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)
Hydroxychloroquine is a drug that has been used to treat malaria and rheumatism. It is recently discovered that Hydroxychloroquine increases 'autophagy'. Autophagy is a process whereby cells eat a part themselves giving them extra energy. Cancer cells use autophagy to survive chemotherapy or hormonal therapy. Also, cancer cells use autophagy to survive in areas of a tumor where there is a low oxygen level. The purpose of this study is to determine whether treatment with the drug Hydroxychloroquine leads to a decrease of autophagy in breast cancer tissue.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hydrochloroquine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Daily HCQ
- description
- Between tumor biopsy and surgery, during 2-3 weeks, breast cancer patients will take daily HCQ, an anti-malaria and anti-rheumatic drug that precludes tumor cells from surviving hypoxia by inhibiting the process of autophagy in these cells
- interventionNames
- Drug: Hydrochloroquine
Primary outcomes (1)
- measure
- hypoxia markers
- timeFrame
- before and after short-term pre-surgical treatment with HCQ
- description
- differences in endogenous hypoxia markers (CA9, PAI-1, VEGF \[Rademakers et al. 2008\]) and autophagy (LC3b \[Rouschop et al. 2010\]) before and after treatment with HCQ. These parameters will be quantified by immunohistochemistry on formalin fixed paraffin embedded tissue from both pretreatment biopsy, and posttreatment surgically obtained material.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients with core-biopsy proven invasive adenocarcinoma of the breast * Any tumor with a size ≥ 1cm (NOT inflammatory breast cancer) * WHO-performance score 0 or 1 * Written informed consent Exclusion Criteria: * Any psychological, familial, sociological or geographical condition potentially hampering adequate informed consent or compliance with the study protocol * Hampered liver or kidney function * Serious gastro-intestinal disease * Neurological disease (including epilepsy) * Hematological disease * Psoriasis * Porphyry * G6PD deficiency * Hypersensitivity for quinine * Use of gold containing drugs, oxyphenbutazone, phenylbutazon, digoxin * Operation for breast cancer foreseen within 14 days after inclusion in the study.
References
Publications (0)
Data not yet available