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

NCT02414776 | Terminated Phase 1

• 1 other identifier: WIRB 20140460
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Estrogen Receptor Positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events as a Measure of the safety profile of orally administered hydroxychloroquine with hormonal therapy

  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

  18 months

Secondary Outcomes (4)

• The recommended phase 2 clinical dose (RP2D) of orally administered hydroxychloroquine with hormonal therapy

  18 months

• The pharmacodynamic (PD) profile of hydroxychloroquine with hormonal therapy

  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)

  18 months

• The disease-free survival (DFS) when adding hydroxychloroquine to hormonal therapy

  18 months

Study Arms (1)

hydroxychloroquine plus hormonal therapy

EXPERIMENTAL

Add hydroxychloroquine to the current hormonal therapy

Drug: hydroxychloroquine

Interventions

hydroxychloroquine DRUG

administration of hydroxychloroquine in combination with the current hormonal therapy

Also known as: Plaquenil

hydroxychloroquine plus hormonal therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Karnofsky Performance Status (KPS) ≥70% and a life expectancy \>3 months.
• 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.
• Absolute neutrophil count \> 1500 mm3, platelet count ≥ 80×109 L, hemoglobin ≥ 8.5 g/dL
• Creatinine clearance ≥ 30 mL/min, total bilirubin ≤ 2 mg/dL, AST/ALT ≤ 3 times the upper limit of normal range
• No remaining grade 2 or higher toxicity from prior cancer therapies unless judged to be clinically insignificant by the Principal Investigator
• At least two (2) weeks from prior major surgery
• 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
• 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 -

You may not qualify if:

• On combination hormonal therapy with everolimus or any other investigational agent
• 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
• Lymphangitic carcinomatosis involving ≥ 50% of the lungs; evidence of metastases involving more than one third of the liver on sonogram or computed tomography
• Lactating females
• Uncontrolled cardiac disease, congestive heart failure, angina or hypertension
• Myocardial infarction or unstable angina within 2 months of treatment
• 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)
• Active clinically serious infection \> CTCAE (version 4.03) Grade 2
• Serious non-healing wound, ulcer, or bone fracture
• Concurrent psychiatric illness/social situations that would limit safety and compliance with study requirements
• Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements
• Currently receiving any other investigational therapeutic agents
• Patients with known glucose-6-phosphate dehydrogenase deficiency, porphyria, cirrhosis or any other conditions with potential significant known risks
• Patients with history of retinal damage

Sponsors & Collaborators

• Western Regional Medical Center: lead

Study Sites (1)

Western Regional Medical Center, Inc.

Goodyear, Arizona, 85338, United States

Location

MeSH Terms

Interventions

Hydroxychloroquine

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jiaxin Niu, MD, PhD

  Western Regional Medical Center, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2015
• First Posted: April 13, 2015
• Study Start: July 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: September 27, 2017

Record last verified: 2017-09

Locations

US (1)