DESTINY-Breast03 Phase 3 Study Results
Study Design
TUXEDO-1 (NCT04752059)
Primary Endpoint: ORR (CNS) by RANO-BM criteria
Secondary Endpoints:
☐
Clinical Benefit Rate (CR+PR+SD ≥6 months)
■ Extracranial Response rate
■ PFS
■ OS
Safety
☐
Ouality of Life
Inclusion/exclusion criteria
Histologically confirmed HER2+ breast cancer
Radiologically documented metastatic disease
Newly diagnosed brain metastases or brain
metastases progressing after prior local
therapy
Measurable disease (RANO-BM criteria)
No indication for immediate local treatment
No indication of leptomeningeal disease
KPS >70%, ECOG <2
Indication for systemic anti-HER2 treatment
Prior exposure to trastuzumab and
pertuzumab
Prior exposure to T-DM1 allowed
Life expectancy of at least 3 months
Age >18 years
LVEF ≥50%
Trastuzumab deruxtecan (5.4
mg/kg IV q3w
Follow up
Treatment until progression, unacceptable
toxicity or withdrawal for any reason
Further treatment according to local standard
Safety FU four weeks after EOT
Survival FU at 3, 9, 18 and 30 months
BM, brain metastasis; BW, body weight; CNS, central nervous system; D1, day 1; EOT, end of treatment; FU, follow up; IV, intravenous; KPS, Karnofsky performance; LVEF, left ventricular
ejection fraction; q3w, once every 3 weeks; RANO, response assessment in neuro-oncology; T-DXd, trastuzumab deruxtecan.
EudraCT: 2020-000981-41.
Simon Two Stage Design
■ RR (CNS) >60% suggests clinically relevant activity
■ RR (CNS) <26% suggests no benefit compared to previous systemic treatment options
☐
■
Stage 1:6 pts. (at least three responses); Stage 2: 9 pts; overall 15 pts. (at least 7 responses)
Type 1 error rate 5%; power 80%
ESMO BC 2022 #165 Mini Oral
Daiichi-Sankyo
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