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
Parallel
Datopotamab Deruxtecan
DrugAntibody-drug conjugate, 100 mg single-use vial, via intravenous infusion per protocol.
Objective Response Rate (ORR) in RANO-BM Criteria
The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on RANO-BM criteria defined protocol section 11.1.1.
Objective Response Rate (ORR)
The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on RECISTv1.1 criteria.
Clinical Benefit Rate at 18 weeks (CBR18)
CBR defined as proportion of participants with defined as intracranial CR, intracranial PR, or stable disease (SD) in both intracranial and extracranial sites ≥ 18 (CBR18) . In the case of intracranial CR or PR, to be considered clinical benefit, extracranial disease must also be stable or better at the time of intracranial response. CBR will be reported for Cohort A and Cohort B only
Clinical Benefit Rate at 24 weeks (CBR24)
CBR defined as proportion of participants with defined as intracranial CR, intracranial PR, or stable disease (SD) in both intracranial and extracranial sites ≥ 24 (CBR24) . In the case of intracranial CR or PR, to be considered clinical benefit, extracranial disease must also be stable or better at the time of intracranial response. CBR will be reported for Cohort A and Cohort B only
Median Progression-Free Survival (PFS)
Progression-free survival based on the Kaplan-Meier method is defined as the duration between randomization and documented disease progression (PD) defined per RANO-BM criteria. or death, or is censored at time of last disease assessment.
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