Autophagy Inhibition Using Hydrochloroquine in Breast Cancer Patients
1 other identifier
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedFirst Posted
Study publicly available on registry
February 9, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedJanuary 20, 2012
January 1, 2012
1 year
December 15, 2010
January 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
hypoxia markers
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.
before and after short-term pre-surgical treatment with HCQ
Secondary Outcomes (1)
autophagy pathway mediators
before and after short-term pre-surgical treatment with HCQ
Study Arms (1)
Daily HCQ
EXPERIMENTALBetween 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Medical Centre Nijmegen
Nijmegen, Gelderland, 6500 HB, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
P. Span, Md
University Medical Centre Nijmegen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2010
First Posted
February 9, 2011
Study Start
January 1, 2011
Primary Completion
January 1, 2012
Last Updated
January 20, 2012
Record last verified: 2012-01