Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Bone Density Conservation Agents

Antineoplastic Agents

All Drugs and Chemicals

Tamoxifen

Hormones

Fulvestrant

Denosumab

Aromatase Inhibitors

Radium Ra 223 dichloride

Hormone Antagonists

Ra-223 dichloride 55 kBq/kg administered as a bolus intravenous (IV) injection (over 1 minute) through a secure in-dwelling catheter on day 1 of the study and then every four weeks thereafter for 6 cycles.

Denosumab 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.

A single hormonal agent (ie, Tamoxifen or Aromatase Inhibitor or Fulvestrant) administered daily while on study. Physician to decide what type of hormone therapy participant will receive.

55 kBq/kg by vein on Day 1 of each 28 day cycle, and then every four weeks thereafter for 6 cycles.

Ra-223 dichloride

120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.

A single hormonal agent administered daily while on study. Physician to decide what type of hormone therapy participant will receive.

Hormone Therapy

Naoto Ueno, MD, PHD

The goal of this clinical research study is to learn if Xofigo® (also called Ra-223 dichloride) combined with hormone therapy and denosumab can help to control breast cancer that has spread to the bones and/or bone marrow. The safety of this study drug combination will also be studied.

This is an investigational study. Denosumab and the hormone therapies used in this study are FDA-approved and commercially available for the treatment of metastatic breast cancer. Ra-223 dichloride is FDA-approved and commercially available for the treatment of bone metastases. It is considered investigational to use the combination of Ra-223 dichloride, hormone therapy and denosumab to treat patients with bone cancer that has spread to the bones.

The study doctor can explain how the study drugs are designed to work.

Up to 36 participants will be enrolled in this study. All will take part at MD Anderson.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive Ra-223 dichloride by vein over no more than 1 minute on Day 1 of each 28-day study cycle.

You will also receive denosumab as an injection under the skin on Day 1 of Cycles 1- 6.

You will also receive hormone therapy while on study. Your doctor will discuss with you what type of hormone therapy you will have, how it will be given, and its risks.

Study Visits:

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

On Day 1 of Cycles 2-5:

* You will have a physical exam.
* Blood (about 2 teaspoons) will be drawn for routine tests.

On Day 1 of Cycle 6:

* Blood (about 2 teaspoons) and urine will be collected for routine tests.
* Blood (about 3 tablespoons) will be drawn for biomarker testing, including genetic biomarkers.
* Blood (about 5 teaspoons) will be drawn to test for CTCs, tumor markers, and genetic testing.
* You will have a PET-CT scan and a bone scan to check the status of the disease. If the doctor thinks it is needed, you will also have an MRI.

Length of Study Participation:

You may continue taking the study drugs for up to 6 cycles. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation will be over after the end-of-study visit.

End-of-Study Visit:

After your last dose of study drug:

* You will have a physical exam.
* Blood (about 2 teaspoons) and urine will be collected for routine tests.
* Blood (about 3 tablespoons) will be drawn for biomarker testing, including genetic biomarkers.
* Blood (about 5 teaspoons) will be drawn to test for CTCs, tumor markers, and genetic testing.
* You will have a PET-CT scan and either a bone scan or a CT scan to check the status of the disease. If the doctor thinks it is needed, you will also have an MRI.
* If the doctor thinks it is needed, you will have a bone marrow aspiration/biopsy to check the status of the disease.

Trial of Ra-223 Dichloride in Combination With Hormonal Therapy and Denosumab in the Treatment of Patients With Hormone-Positive Bone-Dominant Metastatic Breast Cancer

Phase II Trial of Ra-223 Dichloride in Combination With Hormonal Therapy and Denosumab in the Treatment of Patients With Hormone-Positive Bone-Dominant Metastatic Breast Cancer

Disease control rate is defined as the rate of the patients at that time with clinically complete or partial response or stable disease.

Bayer

M.D. Anderson Cancer Center

Ra-223 dichloride 55 kBq/kg administered as a bolus intravenous (IV) injection (over 1 minute) through a secure in-dwelling catheter on day 1 of the study and then every four weeks thereafter for 6 cycles.

Denosumab 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.

A single hormonal agent (ie, Tamoxifen or Aromatase Inhibitor or Fulvestrant) administered daily while on study. Physician to decide what type of hormone therapy participant will receive.

Ra-223 dichloride: 55 kBq/kg by vein on Day 1 of each 28 day cycle, and then every four weeks thereafter for 6 cycles.

Denosumab: 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.

Hormone Therapy: A single hormonal agent administered daily while on study. Physician to decide what type of hormone therapy participant will receive.

Ra-223 Dichloride + Denosumab

Age, Categorical

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

Dr. Naoto T Ueno, Professor, Breast Medical Oncology

1 patient was lost to FU between 6 and 9 months from first dose of Radium -223

Number of Participants With Disease Control Rate at 9 Months

The Number of Participants With Disease Control Rate at 6 Months

Overall Study

Symptoms and General Pathology

Carcinoma

Neoplasm Metastasis

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.

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

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.

Ethnicity (NIH/OMB)

Race (NIH/OMB)

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Trial of Ra-223 Dichloride in Combination With Hormonal Therapy and Denosumab in the Treatment of Patients With Hormone-Positive Bone-Dominant Metastatic Breast Cancer	NCT02366130	Breast Cancer	Ra-223 dichlori... Denosumab Hormone Therapy	18 Years -	M.D. Anderson Cancer Center
Denosumab for Breast Cancer With Bone Mets	NCT01952054	Breast Cancer	Denosumab	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for prolia

Every month we try and update this database with for prolia cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for prolia

Every month we try and update this database with for prolia cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for prolia cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.