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Testing the Addition of Radium Therapy (Radium-223 Dichloride) to the Usual Chemotherapy Treatment (Paclitaxel) for Advanced Breast Cancer That Has Spread to the Bones
NCT04090398 · View on ClinicalTrials.gov ↗
Study Summary
This phase II trial studies how well radium-223 dichloride and paclitaxel work in treating patients with advanced breast cancer that has spread to the bones. Radium-223 dichloride is a radioactive drug that behaves in a similar way to calcium and collects in cancer that has spread to the bones (bone metastases). The radioactive particles in radium-223 dichloride act on bone metastases, killing the tumor cells and reducing the pain that they can cause. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving radium-223 dichloride and paclitaxel may work better in treating patients with metastatic breast cancer compared to paclitaxel alone.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Scan
- PROCEDURE Computed Tomography
- OTHER Electronic Health Record Review
- PROCEDURE Magnetic Resonance Imaging
Study Locations (20)
Florida
- UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach
- University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami
- UM Sylvester Comprehensive Cancer Center at Kendall — Miami
- UM Sylvester Comprehensive Cancer Center at Plantation — Plantation
Kansas
- University of Kansas Clinical Research Center — Fairway
- University of Kansas Cancer Center — Kansas City
- University of Kansas Cancer Center-Overland Park — Overland Park
- University of Kansas Health System Saint Francis Campus — Topeka
- University of Kansas Hospital-Westwood Cancer Center — Westwood
California
- City of Hope Comprehensive Cancer Center — Duarte
- UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange
- University of California Davis Comprehensive Cancer Center — Sacramento
Illinois
- University of Chicago Comprehensive Cancer Center — Chicago
- UC Comprehensive Cancer Center at Silver Cross — New Lenox
- University of Chicago Medicine-Orland Park — Orland Park
Michigan
- Wayne State University/Karmanos Cancer Institute — Detroit
- Weisberg Cancer Treatment Center — Farmington Hills
Alabama
- University of Alabama at Birmingham Cancer Center — Birmingham
Kentucky
- University of Kentucky/Markey Cancer Center — Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2020-08-04 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04090398
The ClinicalTrials.gov registry entry for NCT04090398 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Anatomic Stage IV Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions — of which Biospecimen Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04090398 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Florida, Kansas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04090398 about?
NCT04090398 is a clinical study titled "Testing the Addition of Radium Therapy (Radium-223 Dichloride) to the Usual Chemotherapy Treatment (Paclitaxel) for Advanced Breast Cancer That Has Spread to the Bones". This phase II trial studies how well radium-223 dichloride and paclitaxel work in treating patients with advanced breast cancer that has spread to the bones. Radium-223 dichloride is a radioactive drug that behaves in a similar way to calcium and collects in cancer that has spread to the bones (bone...
What is the current status of trial NCT04090398?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2020-08-04. Estimated completion is 2026-06-30.
What conditions does trial NCT04090398 study?
This clinical trial studies the following conditions: Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Malignant Neoplasm in the Bone, Metastatic HER2-Negative Breast Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04090398?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Scan (PROCEDURE), Computed Tomography (PROCEDURE), Electronic Health Record Review (OTHER), Magnetic Resonance Imaging (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04090398?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04090398 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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