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Hydroxychloroquine in Metastatic Estrogen Receptor-Positive Breast Cancer Progressing on Hormonal Therapy | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

Phase Ib/II Study of Hydroxychloroquine in Metastatic ER-Positive Breast Cancer Progressing on Hormonal Therapy

NCT02414776•Western Regional Medical Center

View on ClinicalTrials.gov

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.

Detailed Description

To determine the number of patients with adverse effects To assess the clinical response to the combination

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

Locations (1)

Western Regional Medical Center, Inc.

Goodyear, Arizona, United States

Key Dates

Start Date

July 1, 2014

Primary Completion Date

November 1, 2015

Completion Date

November 1, 2015

Last Updated

September 27, 2017

Enrollment

ACTUAL participants

Conditions

Estrogen Receptor Positive Breast Cancer

Interventions

hydroxychloroquine

DRUG

FDG PET/CT in Breast Cancer Bone Mets

NCT01996046

Estrogen Receptor Positive Breast CancerBone Metastases

View study

COMPLETEDPHASE3

Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer

NCT00066690

Estrogen Receptor Positive Breast CancerProgesterone Receptor Positive Tumor+6 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 27, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

FDG PET/CT in Breast Cancer Bone Mets

Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer

[18F]FES PET/CT in Endocrine Refractory Breast Cancer

[18F]Fluoroestradiol-PET/CT Companion Imaging Study to the FORESEE Trial

A Breast Cancer Treatment Decision Aid for Women Aged 70 and Older