The purpose of this study is to test the safety and effectiveness of the study drug datopotamab deruxtecan in participants with metastatic breast cancer that has spread to the brain.
The name of the study drug used in this research study is:
Datopotamab deruxtecan (a type of antibody-drug conjugate)
Metastatic breast cancer that is pathologically confirmed to be HER2-negative according to 2018 ASCO/CAP guidelines 55.
Radiological confirmation of metastatic disease.
Cohorts A and B: Presence of newly diagnosed brain metastases or brain metastases progressing after prior local and/or systemic therapy.
Cohorts A and B: Participants must have a baseline MRI of the brain performed with and without gadolinium contrast, and must have central nervous system metastases with at least one measurable brain metastasis ≥ 1.0 cm in size (per RANO-BM) that has not been irradiated, or has progressed despite prior radiation therapy and/or systemic therapy (in the opinion of the treating physician). For cohorts A and B, head CT with contrast may be used in place of MRI at baseline and throughout the trial if MRI is contraindicated and the participant's CNS metastases are clearly measurable by head CT.
Visceral crisis or impending visceral crisis
CNS complications for whom urgent neurosurgical intervention is indicated (i.e., resection, shunt placement)
Indication for immediate local therapy to CNS lesion(s) as defined by local standard
Evidence of significant (i.e., symptomatic) intracranial hemorrhage
Sarah Sammons, MD
Lead sponsor
Dana-Farber Cancer Institute
Sponsor institution
Daiichi Sankyo
Collaborator