NCT00379197

Brief Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Naltrexone may fight breast cancer by blocking the use of estrogen by the tumor cells. Naltrexone may also stop the growth of breast cancer by impairing blood flow to the tumor. PURPOSE: This phase II trial is studying how well naltrexone works in treating women with metastatic breast cancer that is no longer responsive to previous hormone therapy.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Jul 2006

Longer than P75 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2006

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

May 19, 2017

Completed
Last Updated

December 28, 2017

Status Verified

December 1, 2017

Enrollment Period

6.8 years

First QC Date

September 19, 2006

Results QC Date

April 22, 2015

Last Update Submit

December 3, 2017

Conditions

Breast Cancer

Keywords

stage IV breast cancer, estrogen receptor positiverecurrent breast cancerhormone-refractory, metastatic breast cancer

Outcome Measures

Primary Outcomes (1)

  • Disease Response

    A response is the number of participants whose tumor demonstrated a decrease in FDG uptake (SUV) by 50% or greater in at least one of the metastatic sites as measured by PET imaging at the end of 4 weeks of treatment compared to baseline.

    Week 4

Secondary Outcomes (1)

  • Median Time to Event

    From Baseline to 1 Year

Study Arms (1)

Naltrexone

EXPERIMENTAL

Naltrexone 50 mg will be taken orally once a day every day of a 28 day treatment course (cycle 1) and continue for another identical 28 day treatment (cycle 2) . PET scan will be performed after cycle 1 and cycle 2 complete.

Drug: naltrexoneProcedure: PET scan

Interventions

naltrexoneDRUG

Naltrexone 50 mg will be orally taken once daily for 28 day (cycle 1), and continues once daily for another 28 days (cycle 2) without interval.

Also known as: REVIA
Naltrexone
PET scanPROCEDURE

Patients will receive PET scan approximately one hour after being injected with 2-Deoxy-2-\[18F\]fluoro-D-Glucose (FDG). PET scans will be performed after the completion of cycle 1 and cycle 2 and during the 1 year follow-up.

Also known as: Positron-emission tomography scan
Naltrexone

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Metastatic, hormone-receptor positive breast cancer
  • Disease that has progressed despite previous systemic hormonal therapy. Hormone therapy must be terminated at least 2 weeks prior to study enrollment.
  • Prior chemotherapy, immunotherapy, or biological therapy is allowed if at least 3 weeks since last treatment. Patient must recover from the acute toxic effects of the treatment prior to study enrollment.
  • Measurable disease as defined by solid tumor response (RECIST) criteria or non-measurable bone disease that is Positron-emission tomography (PET) avid
  • Karnofsky performance status \>70%
  • Female, age 18 years or older
  • Adequate organ function within 14 days of study enrollment including the following:
  • Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) ≥ 1.5 x 10\^9/L, platelets \>75 x 10\^9/L, and hemoglobin \> 8 g/dL
  • Hepatic: bilirubin ≤ 2 times the upper limit of normal (× ULN), aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2 × ULN. (AST and ALT ≤ 5 × ULN is acceptable if liver has tumor involvement)
  • Renal: creatinine ≤ 2 times the upper limit of normal
  • Women of childbearing potential are required to use an effective method of contraception (ie, a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) during the study and for 3 months after the last dose of study drug.
  • Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

You may not qualify if:

  • Brain metastases unless stable for 1 month or more following radiation therapy.
  • Pregnant or lactating women. PET-CT is not approved during pregnancy. A negative urine or serum pregnancy test is required for all females of child bearing potential within 7 days prior to study entry. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
  • Use of any short-acting or long-acting opioid medication (including morphine, meperidine, oxycodone, hydromorphone, hydrocodone, fentanyl, tramadol) within 10 days prior to study enrollment
  • Pain uncontrolled with the use of non-narcotic drugs (acetaminophen or non-steroidal medications)
  • History of sensitivity to naltrexone
  • Acute hepatitis or liver failure
  • Immunosuppressive therapy for patients with autoimmune diseases, organ transplant, or other indications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

  • Vijayakumar J, Haddad T, Gupta K, Sauers J, Yee D. An open label phase II study of safety and clinical activity of naltrexone for treatment of hormone refractory metastatic breast cancer. Invest New Drugs. 2023 Feb;41(1):70-75. doi: 10.1007/s10637-022-01317-4. Epub 2022 Nov 28.

    PMID: 36441436DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

NaltrexoneMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

NaloxoneMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Results Point of Contact

Title
Dr. Douglas Yee, MD
Organization
University of Minnesota, Dept. Medicine
yeexx006@umn.edu
612-273-5700

Study Officials

  • Douglas Yee, MD

    Masonic Cancer Center, University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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

September 19, 2006

First Posted

September 21, 2006

Study Start

July 1, 2006

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

December 28, 2017

Results First Posted

May 19, 2017

Record last verified: 2017-12

Locations

US(1)