Overview

Autophagy Inhibition Using Hydrochloroquine in Breast Cancer Patients

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Radboud University
Treatments:
Hydroxychloroquine
Criteria
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.