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

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

Brief description of study

The purpose of the study is to determine the safety and efficacy of the combination of Radium-223 dichloride and paclitaxel. We want to know if the combination of Radium-223 dichloride and paclitaxel can prolong progression-free survival (PFS) when compared to paclitaxel alone. Participants will be randomized into 1:1 to receive Radium-223 dichloride and paclitaxel or paclitaxel alone. The randomization procedure will stratify participants by hormone receptor status or presence of visceral metastasis.

Clinical Study Identifier: s21-00695

ClinicalTrials.gov Identifier: NCT04090398

Other Investigators: Yelena Novik, Fabio Ponzo, Kent P Friedman, Marleen I Meyers, Maryann J Kwa, Sylvia Adams, Caitlin Elizabeth Ryan, Ruth Oratz, Douglas K Marks.

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Perlmutter Cancer Center

Clinical Trials & Research Studies