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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (26 items) and avoid the listed exclusions (21 items).
Location: University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Patients with peripheral neuropathy \> grade 1
- Patients who have not recovered from AEs due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia
- Patients who have had chemotherapy or immunotherapy with checkpoint inhibitor within 4 weeks prior to treatment. Patient who receives radiation therapy or hormone therapy within 2 weeks prior to treatment are excluded. For patients on trial therapy prior to study enrollment, washout period of 6 times the half-life of previously administered investigational agents prior to starting radium-223 dichloride is required
- Prior therapy with radionuclides (e.g., strontium, samarium, rhenium, radium)
- Patients who are receiving any other investigational agents. Vaccination for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is allowed as well as any therapy as required for the treatment of active coronavirus disease 2019 (COVID-19) infection
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to radium-223 dichloride or other agents used in study
- Patients with psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study because radium-223 dichloride is an alpha particle-emitting radiopharmaceutical agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with radium-223 dichloride, breastfeeding should be discontinued if the mother is treated with radium-223 dichloride. These potential risks may also apply to other agents used in this study
- Imminent/established spinal cord compression, pathological fracture in weight bearing bones or bone lesion with soft tissue component unless treated as appropriate with radiation and/or surgery before starting on trial
- Prior hemibody external radiotherapy
- Patients must not have an active infection requiring systemic treatment
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (30 Sites)
- University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
- City of Hope Comprehensive Cancer Center — Duarte, California
- UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California
- University of California Davis Comprehensive Cancer Center — Sacramento, California
- UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables, Florida
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach, Florida
- University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida
- UM Sylvester Comprehensive Cancer Center at Kendall — Miami, Florida
- UM Sylvester Comprehensive Cancer Center at Plantation — Plantation, Florida
- University of Chicago Comprehensive Cancer Center — Chicago, Illinois
- UC Comprehensive Cancer Center at Silver Cross — New Lenox, Illinois
- University of Chicago Medicine-Orland Park — Orland Park, Illinois
- University of Kansas Clinical Research Center — Fairway, Kansas
- University of Kansas Cancer Center — Kansas City, Kansas
- University of Kansas Cancer Center-Overland Park — Overland Park, Kansas
- University of Kansas Health System Saint Francis Campus — Topeka, Kansas
- University of Kansas Hospital-Westwood Cancer Center — Westwood, Kansas
- University of Kentucky/Markey Cancer Center — Lexington, Kentucky
- Wayne State University/Karmanos Cancer Institute — Detroit, Michigan
- Weisberg Cancer Treatment Center — Farmington Hills, Michigan
- University of Kansas Cancer Center - North — Kansas City, Missouri
- University of Kansas Cancer Center - Lee's Summit — Lee's Summit, Missouri
- University of Kansas Cancer Center at North Kansas City Hospital — North Kansas City, Missouri
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center — Lebanon, New Hampshire
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.