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Computed Tomography / Metastatic HER2 Negative Breast Carcinoma / Bone Scan · Phase 2 Trial
ClinicalTrials.gov · September 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 2 trial registration for radium-223 dichloride combined with paclitaxel in metastatic bone-positive breast cancer, with progression-free survival as the primary endpoint. No results have been posted in this registry record as of the current snapshot; the study status is active but not currently recruiting.
Phase 2, Interventional, Randomized, Parallel, Open label, Treatment purpose. Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma, Metastatic Malignant Neoplasm in the Bone; age from 18 Years. Intervention: Arm I (paclitaxel, radium Ra 223 dichloride). Compared with: Arm II (paclitaxel) — Active Comparator. n = 70. 30 sites: United States.
This is a Phase 2 trial registration for radium-223 dichloride combined with paclitaxel in metastatic bone-positive breast cancer, with progression-free survival as the primary endpoint. No results have been posted in this registry record as of the current snapshot; the study status is active but not currently recruiting.
This is a registry record only; no efficacy or safety results are reported. Efficacy and safety data must await publication of trial results.
The source did not state who this applies to in practice.
This is a Phase 2 interventional trial registration with no reported results; the study is active but not yet recruiting and outcome data are not posted in the registry.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT04090398). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 70 participants (ESTIMATED). Conditions: Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma, Metastatic Malignant Neoplasm in the Bone. Interventions: PROCEDURE: Biospecimen Collection; PROCEDURE: Bone Scan; PROCEDURE: Computed Tomography; OTHER: Electronic Health Record Review; PROCEDURE: Magnetic Resonance Imaging; DRUG: Paclitaxel; RADIATION: Radium Ra 223 Dichloride; PROCEDURE: Single Photon Emission Computed Tomography. Primary outcome measures: Progression-free survival (PFS) , From randomization to the first documented tumor progression or death due to any cause, whichever occurred first, assessed up to 2 years. Brief 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.
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