Phase II of Naltrexone in Hormone-Refractory Metastatic Breast Cancer
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ClinicalTrials.gov Identifier: NCT00379197 |
Recruitment Status
:
Terminated
(slow accrual)
First Posted
: September 21, 2006
Results First Posted
: May 19, 2017
Last Update Posted
: December 28, 2017
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Tracking Information | ||||
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First Submitted Date ICMJE | September 19, 2006 | |||
First Posted Date ICMJE | September 21, 2006 | |||
Results First Submitted Date | April 22, 2015 | |||
Results First Posted Date | May 19, 2017 | |||
Last Update Posted Date | December 28, 2017 | |||
Study Start Date ICMJE | July 2006 | |||
Actual Primary Completion Date | May 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Disease Response [ Time Frame: Week 4 ] 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.
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Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | Complete list of historical versions of study NCT00379197 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Median Time to Event [ Time Frame: From Baseline to 1 Year ] First time when maximum SUV is higher than that at baseline within 1 year of study entry.
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Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Phase II of Naltrexone in Hormone-Refractory Metastatic Breast Cancer | |||
Official Title ICMJE | Phase II Study of Naltrexone for the Treatment of Hormone-Refractory, Metastatic Breast Cancer | |||
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. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is an open-label study. Patients receive oral naltrexone once daily for 8 weeks in the absence of disease progression or unacceptable toxicity. After 8 weeks, patients may continue naltrexone off study at the discretion of the physician. Patients undergo fludeoxyglucose F 18 positron emission tomography-CT scans at baseline, week 4, week 8, and periodically thereafter. After completion of study treatment, patients are followed for up to 1 year. PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Breast Cancer | |||
Intervention ICMJE |
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Study Arms | Experimental: Naltrexone
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.
Interventions:
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
13 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date | May 2013 | |||
Actual Primary Completion Date | May 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00379197 | |||
Other Study ID Numbers ICMJE | 2006LS016 UMN-0604M85308 ( Other Identifier: IRB, University of Minnesota ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Masonic Cancer Center, University of Minnesota | |||
Study Sponsor ICMJE | Masonic Cancer Center, University of Minnesota | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Masonic Cancer Center, University of Minnesota | |||
Verification Date | December 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |