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Hydroxychloroquine in Metastatic Estrogen Receptor-Positive Breast Cancer Progressing on Hormonal Therapy (ABC01)

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ClinicalTrials.gov Identifier: NCT02414776
Recruitment Status : Terminated (PI Leaving Site)
First Posted : April 13, 2015
Last Update Posted : September 27, 2017
Sponsor:
Information provided by (Responsible Party):
Western Regional Medical Center

Brief Summary:

To determine the safety and tolerability of orally administered hydroxychloroquine with hormonal therapy.

To assess the response rate of hydroxychloroquine in combination with hormonal therapy.


Condition or disease Intervention/treatment Phase
Estrogen Receptor Positive Breast Cancer Drug: hydroxychloroquine Phase 1

Detailed Description:

To determine the number of patients with adverse effects

To assess the clinical response to the combination


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase Ib/II Study of Hydroxychloroquine in Metastatic ER-Positive Breast Cancer Progressing on Hormonal Therapy
Study Start Date : July 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: hydroxychloroquine plus hormonal therapy
Add hydroxychloroquine to the current hormonal therapy
Drug: hydroxychloroquine
administration of hydroxychloroquine in combination with the current hormonal therapy
Other Name: Plaquenil




Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of the safety profile of orally administered hydroxychloroquine with hormonal therapy [ Time Frame: 18 months ]
    Assess the dose-limiting side effects such as neutropenia, anemia, or thormbocytopenia, or non-hematologic side effects nausea, vomiting, diarrhea, or vision problems at the study dose


Secondary Outcome Measures :
  1. The recommended phase 2 clinical dose (RP2D) of orally administered hydroxychloroquine with hormonal therapy [ Time Frame: 18 months ]
    orally administered hydroxychloroquine with hormonal therapy

  2. The pharmacodynamic (PD) profile of hydroxychloroquine with hormonal therapy [ Time Frame: 18 months ]
    microtubule-associated protein 1 light chain 3 b (LC3b) level in the biopsy, WBCs in pre- and post-treatment samples

  3. The anti-tumor activity of hydroxychloroquine with hormonal therapy with clinical benefit rate (CBR). Clinical benefits are defined as complete remission (CR), partial remission (PR) and stable disease (SD) [ Time Frame: 18 months ]
    The anti-tumor activity of hydroxychloroquine with hormonal therapy with clinical benefit rate (CBR). Clinical benefits are defined as complete remission (CR), partial remission (PR) and stable disease (SD)

  4. The disease-free survival (DFS) when adding hydroxychloroquine to hormonal therapy [ Time Frame: 18 months ]
    The disease-free survival (DFS) when adding hydroxychloroquine to hormonal therapy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients ≥ 18 years of age with histologically confirmed, metastatic ER + breast cancer with clinical progression of disease (including radiographically stable disease with at least 50% increment of an elevated tumor marker by two measurements at least 2 weeks apart (this particular tumor marker will be used for disease status assessment in the study) on current hormonal therapy with PFS for at least 3 months.
  2. Karnofsky Performance Status (KPS) ≥70% and a life expectancy >3 months.
  3. Participants must have at least one target visceral lesion that allows for evaluation of tumor response or in the case of bone-only metastases, patients need to have a positive imaging study such as bone scan, magnetic resonance imaging (MRI) or positron emission tomography-computed tomography (PET-CT) or CT, and an elevated tumor marker at least twice as high as upper limit.
  4. Absolute neutrophil count > 1500 mm3, platelet count ≥ 80×109 L, hemoglobin ≥ 8.5 g/dL
  5. Creatinine clearance ≥ 30 mL/min, total bilirubin ≤ 2 mg/dL, AST/ALT ≤ 3 times the upper limit of normal range
  6. No remaining grade 2 or higher toxicity from prior cancer therapies unless judged to be clinically insignificant by the Principal Investigator
  7. At least two (2) weeks from prior major surgery
  8. Willingness to provide permission to biopsy one of the lesions if applicable before the study (All the patients are encouraged to have post-therapy biopsy upon progression of disease, but it is optional) as well as blood samples for pertinent laboratory studies
  9. Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must be willing to use an acceptable non-hormonal contraceptive method (abstinence, or double barrier method) for the duration of the study and for 30 days following the last dose of study drug, and must have a negative urine or serum pregnancy test within 2 weeks prior to beginning treatment on this trial -

Exclusion Criteria:

  1. On combination hormonal therapy with everolimus or any other investigational agent
  2. Patients have symptomatic untreated brain metastasis or leptomeningeal metastases or treated but still symptomatic requiring the use of steroid 18Jul2014 Protocol v3: ABC 01 Anti-Autophagy for Met Breast Cancer Page 4 of 16
  3. Lymphangitic carcinomatosis involving ≥ 50% of the lungs; evidence of metastases involving more than one third of the liver on sonogram or computed tomography
  4. Lactating females
  5. Uncontrolled cardiac disease, congestive heart failure, angina or hypertension
  6. Myocardial infarction or unstable angina within 2 months of treatment
  7. Known human immunodeficiency virus (HIV) infection or chronic active Hepatitis B or C (patients are NOT required to be tested for the presence of such viruses prior to therapy on this protocol)
  8. Active clinically serious infection > CTCAE (version 4.03) Grade 2
  9. Serious non-healing wound, ulcer, or bone fracture
  10. Concurrent psychiatric illness/social situations that would limit safety and compliance with study requirements
  11. Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements
  12. Currently receiving any other investigational therapeutic agents
  13. Patients with known glucose-6-phosphate dehydrogenase deficiency, porphyria, cirrhosis or any other conditions with potential significant known risks
  14. Patients with history of retinal damage

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02414776


Locations
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United States, Arizona
Western Regional Medical Center, Inc.
Goodyear, Arizona, United States, 85338
Sponsors and Collaborators
Western Regional Medical Center
Investigators
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Principal Investigator: Jiaxin Niu, MD, PhD Western Regional Medical Center, Inc.

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Responsible Party: Western Regional Medical Center
ClinicalTrials.gov Identifier: NCT02414776     History of Changes
Other Study ID Numbers: WIRB 20140460
First Posted: April 13, 2015    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
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Hydroxychloroquine
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents