OncRef

Clinical Trial: NCT04090398

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 2

Lead Sponsor:National Cancer Institute (NCI)
Information Provided By:National Cancer Institute (NCI)
Last Update Posted:2026-09-18

Study Overview

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.

Official Title

Phase II Trial of Radium-223 Dichloride in Combination With Paclitaxel in Patients With Bone Metastatic Breast Cancer

Conditions

Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma, Metastatic Malignant Neoplasm in the Bone

Intervention / Treatment

  • 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

Other Study ID Numbers

  • NCI-2019-06088
  • NCI-2019-06088
  • 052001
  • 10302
  • 10302
  • UM1CA186644
  • UM1CA186716

Start Date (Actual)

2020-08-04

Primary Completion Date (Estimated)

2027-06-30

Study Completion Date (Estimated)

2027-06-30

Enrollment (Estimated)

70

Study Type

Interventional

Phase

Phase 2