NCT01292408

Autophagy Inhibition Using Hydrochloroquine in Breast Cancer Patients:a Pilot Study

Status unknown Phase 2 Last updated 19 January 2012

What this trial tests

Phase 2 trial testing Hydrochloroquine in Breast Cancer in 20 participants. Status unknown.

Timeline

1 January 2011

Primary endpoint
1 January 2012

Quick facts

Lead sponsor	Radboud University Medical Center
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	1 January 2011
Primary completion	1 January 2012
Sites	1 location across Netherlands

Drugs / interventions tested

• Hydrochloroquine — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Radboud University Medical Center

Who can join

Eligibility, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• hypoxia markers
  Time frame: before and after short-term pre-surgical treatment with HCQ
  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.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Autophagy and chemotherapy resistance: a promising therapeutic target for cancer treatment.
   Sui X, Chen R, Wang Z, Huang Z, et al · · 2013 · cited 940× · PMID 24113172 · DOI 10.1038/cddis.2013.350
2. Autophagy and human diseases.
   Jiang P, Mizushima N. · · 2014 · cited 611× · PMID 24323045 · DOI 10.1038/cr.2013.161
3. Role of lysosomes in physiological activities, diseases, and therapy.
   Zhang Z, Yue P, Lu T, Wang Y, et al · · 2021 · cited 238× · PMID 33990205 · DOI 10.1186/s13045-021-01087-1
4. Repurposing Drugs in Oncology (ReDO)-chloroquine and hydroxychloroquine as anti-cancer agents.
   Verbaanderd C, Maes H, Schaaf MB, Sukhatme VP, et al · · 2017 · cited 198× · PMID 29225688 · DOI 10.3332/ecancer.2017.781
5. Targeting autophagy during cancer therapy to improve clinical outcomes.
   Levy JM, Thorburn A. · · 2011 · cited 192× · PMID 21440002 · DOI 10.1016/j.pharmthera.2011.03.009
6. Therapeutic targeting of autophagy in disease: biology and pharmacology.
   Cheng Y, Ren X, Hait WN, Yang JM. · · 2013 · cited 188× · PMID 23943849 · DOI 10.1124/pr.112.007120
7. Tumor suppression and promotion by autophagy.
   Ávalos Y, Canales J, Bravo-Sagua R, Criollo A, et al · · 2014 · cited 141× · PMID 25328887 · DOI 10.1155/2014/603980
8. Autophagy in tumor suppression and cancer therapy.
   Kung CP, Budina A, Balaburski G, Bergenstock MK, et al · · 2011 · cited 129× · PMID 21967333 · DOI 10.1615/critreveukargeneexpr.v21.i1.50