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Denosumab

Participants receive a single subcutaneous (SC) administration of Denosumab 120 mg every 4 weeks (+/- 5days). Starting week 5, in addition to receiving Denosumab every 4 weeks, participants receive a hormonal agent chosen by each physician, excluding the agent that participants received at adjuvant therapy setting.

120 mg subcutaneously on Day 1 of every 28 day cycle.

Naoto Ueno, MD, PHD

The goal of this clinical research study is to learn if denosumab in combination with a hormonal drug can help lower the number of circulating tumor cells (CTCs) in patients with breast cancer that has spread to the bone. The safety of this combination will also be studied.

This is an investigational study. Denosumab is FDA approved and commercially available to prevent bone-related events caused by breast cancer that has spread to the bone. Using denosumab to lower CTCs in patients with breast cancer that has spread to the bone is investigational.

You may have the option of continuing denosumab after the study ends.

Up to 35 patients will take part in this study. All will be enrolled at MD Anderson.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive denosumab through a needle under your skin on Day 1 of each 28-day study cycle.

Starting on Day 1 of week 4, you will also begin taking a hormonal drug. The study doctor will choose the hormonal drug you receive based on your previous hormonal therapy for breast cancer. The study doctor will give you instructions for taking your hormonal drug.

Study Visits:

On Day 1 of week 4:

* You will have a physical exam
* Blood (about 3 tablespoons) will be drawn for routine tests
* Blood (about 5 teaspoons) will be drawn for CTC testing and to check your immune system.
* Urine will be collected to test for a biomarker that is used to measure the rate of bone breakdown.
* If the study doctor thinks it is needed, you will have a PET scan, a bone scan, or an MRI to check the status of the disease.

On Day 1 of Cycle 2 and Cycle 3, blood (about 1 teaspoon) will be drawn for routine tests.

Length of Study:

You may receive the denosumab and hormonal therapy combination for up to 13 weeks. You will be taken off study if the disease gets worse or intolerable side effects occur.

End of Study Visit:

After your last dose of the study drug, the following tests and procedures will be performed:

* You will have a physical exam.
* Blood (about 3 tablespoons) will be drawn for routine tests.
* Blood (about 5 teaspoons) will be drawn for CTC testing and to check your immune system.
* Urine will be collected to test for a biomarker that is used to measure the rate of bone breakdown.
* If the study doctor thinks it is needed, you will have a PET scan, a bone scan, or an MRI to check the status of the disease.

Denosumab for Breast Cancer With Bone Mets

Phase II Study of Denosumab to Define the Role of Bone Related Biomarkers in Breast Cancer Bone Metastasis

The difference in number of CTCs in 7.5 ml whole blood from baseline to week4. CTC reduction from baseline to week4 is statistically analyzed using the two-sided paired t-test with the significance level of 0.05.

The change in Her2, Muc-1, GA733-2 (EpCAM), Twist, Akt, PI3K and ALDH-1 in CTCs after 1 st cycle of treatment with denosumab.

The collection urine is performed at baseline, at week4 and the end of 3rd cycle (week13) to evaluate the level of N-telopeptide.

Amgen

M.D. Anderson Cancer Center

A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.

Subcutaneous administration of Denosumab 120 mg every 4 weeks (+/- 5days). Starting week 5, also receive a hormonal agent chosen by physician.

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Ueno,Naoto,M.D., PH.D. / Breast Medical Oncology

The primary objective could not be met due to technical issues.

Spots Global Cancer Trial Database for cancer that has spread to the bone