Breast CancerPhase 2NCT00379197
Phase II of Naltrexone in Hormone-Refractory Metastatic Breast Cancer
A Phase 2 study testing naltrexone and PET scan in people with Breast Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- naltrexone and PET scan
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to May 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Phase II Study of Naltrexone for the Treatment of Hormone-Refractory, Metastatic Breast Cancer
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.
Read the detailed description
OBJECTIVES:
Primary
- Determine the efficacy of naltrexone in women with hormone-refractory, metastatic breast cancer as measured by serial fludeoxyglucose F 18 positron emission tomography-CT scans.
Secondary
- Determine the safety of naltrexone in these patients.
- Determine the median time to event (first time when maximum specific uptake values is higher than that at baseline) within 1 year of study entry.
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.
- Conditions
- Breast Cancer
- Being tested
- naltrexone, PET scan
- Keywords
- stage IV breast cancer, estrogen receptor positive, recurrent breast cancer, hormone-refractory, metastatic breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
naltrexoneDrug
Also called REVIA
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.
PET scanProcedure or surgery
Also called Positron-emission tomography scan
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: naltrexone; Procedure: PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 4
Secondary outcomes (1)
Median Time to Event
First time when maximum SUV is higher than that at baseline within 1 year of study entry.
Measured: From Baseline to 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2006 (estimated)
- Study startJul 2006
- Primary completionMay 2013
- Study completionMay 2013
Why it stopped: slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Douglas Yee, MD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00379197
- Sponsor's protocol ID
- 2006LS016
- Other IDs
- UMN-0604M85308
- Status last verified
- Dec 2017
- First submitted
- 19 Sep 2006
- Last updated
- 28 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 36441436
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Naltrexone for the Treatment of Hormone-Refractory, Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00379197
- Acronym / sponsor ID
- 2006LS016
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, estrogen receptor positive, recurrent breast cancer, hormone-refractory, metastatic breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow accrual
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 21 Sep 2006 (estimated)
- Results
- Posted 19 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
Primary
- Determine the efficacy of naltrexone in women with hormone-refractory, metastatic breast cancer as measured by serial fludeoxyglucose F 18 positron emission tomography-CT scans.
Secondary
- Determine the safety of naltrexone in these patients.
- Determine the median time to event (first time when maximum specific uptake values is higher than that at baseline) within 1 year of study entry.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Naltrexone | Experimental | Drug: naltrexone, Procedure: PET scanNaltrexone 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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%
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| naltrexoneAlso: REVIANaltrexone 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. | Drug | Naltrexone |
| PET scanAlso: Positron-emission tomography scanPatients 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. | Procedure or surgery | Naltrexone |
Primary outcome
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.
1 secondary outcome
Median Time to Event
Time frame: From Baseline to 1 Year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36441436Vijayakumar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas Yee, MD principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing naltrexone and PET scan in people with Breast Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Response (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00379197, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2017.