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NCT02366130 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
NCT02366130: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT02366130 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 45 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02366130, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Disease control rate is defined as the rate of the patients at that time with clinically complete or partial response or stable disease.
Interventions
- DRUG Denosumab
- DRUG Hormone Therapy
- DRUG Ra-223 dichloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2015-02-11 |
| Est. Completion | 2020-12-16 |
| Phase | Phase 2 |
What the finished NCT02366130 record still lists
NCT02366130 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 3 interventions - of which Denosumab is the first listed.
NCT02366130 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02366130 about?
NCT02366130 is a clinical study titled "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". 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 i...
What is the current status of trial NCT02366130?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2015-02-11. Estimated completion is 2020-12-16.
What interventions are being tested in trial NCT02366130?
The interventions under investigation include: Denosumab (DRUG), Hormone Therapy (DRUG), Ra-223 dichloride (DRUG).
Who is sponsoring clinical trial NCT02366130?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02366130's enrollment target sits among peer trials
45 1296th of 2000 higher than 679 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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