Symptoms and General Pathology

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Breast Neoplasms

Breast Diseases

Skin Diseases

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Hormones

Naltrexone

Estrogens

Ethanol

Narcotics

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.

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.

naltrexone

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.

PET scan

Douglas Yee, MD

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.

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.

Phase II of Naltrexone in Hormone-Refractory Metastatic Breast Cancer

Phase II Study of Naltrexone for the Treatment of Hormone-Refractory, Metastatic Breast Cancer

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.

First time when maximum SUV is higher than that at baseline within 1 year of study entry.

Masonic Cancer Center, University of Minnesota

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 scan will be performed after the completion of cycle 1 and cycle 2 and during the 1 year follow-up compared to the baseline level of FDG uptake.

Naltrexone Treatment

Naltrexone hydrochloride 50 mg will be taken once a day every day of a 28 day treatment course. Positron-emission tomography (PET) / computed tomography (CT) given with injection of 2-Deoxy-2-\[18F\]fluoro-D-Glucose (FDG).

naltrexone hydrochloride: Naltrexone should be taken with water or food, and it can be taken at any time day. Naltrexone 50 mg will be taken once a day every day of a 28 day treatment course.

Positron-emission tomography (PET) / computed tomography (CT): Given with injection of 2-Deoxy-2-\[18F\]fluoro-D-Glucose (FDG). Follow-up scans will be performed after the completion of cycle 1 and cycle 2 and during the 1 year follow-up.

Age, Categorical

Female only

Sex/Gender, Customized

United States

Region of Enrollment

Dr. Douglas Yee, MD

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 scan will be performed as baseline level at the beginning of study and after the completion of cycle 1 and cycle 2.

Disease Response

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.

naltrexone: 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 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.

One of the 8 participants did not have an increase in SUV above baseline at 8 weeks, but no further PET scans were performed after 8 weeks. The reported median value is for the remaining 7 participants.

Median Time to Event

Naltrexone 50 mg taken orally once daily for 2 28-day cycles with an option to continue on Naltrexone at the discretion of the treating physician.

Spots Global Cancer Trial Database for stage iv breast cancer, estrogen receptor positive