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DESTINY-Breast01: Brain Metastases Subgroup Analysis (August 1, 2019 DCO Date)

Key Inclusion Criteria

Key Inclusion Criteria1

Patients were included if1:

  • They had BM that were treated, asymptomatic, or did not require therapy to control symptoms
  • They had radiation, surgery, or other therapy (including steroids or anticonvulsants) to control symptoms more than 60 days before randomization
  • Brain imaging was performed every 6 weeks for patients with a history of BM

Endpoints

Endpoints1

Primary1:

Confirmed ORR by independent central imaging facility review per RECIST v1.1

Secondary1:

investigator-assessed ORR, DCR, DOR, CBR, PFS, OS, PK, and safety

Abbreviations

BM = brain metastases

;

CBR = clinical benefit rate

;

DCO = data cut-off

;

DCR = disease control rate

;

DOR = duration of response

;

ORR = objective response rate

;

OS = overall survival 

;

PFS = progression-free survival 

;

PK = pharmacokinetics

;

RECIST = Response Evaluation Criteria for Solid Tumors

References

1. Modi S, Saura C, Yamashita T, et al. Trastuzumab deruxtecan in previously treated HER2-positive breast cancer. N Engl J Med 2020;382:610-621.

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