DESTINY-Breast01 Trial

ENHERTU efficacy evaluated in DESTINY-Breast01

A Phase 2, multicenter, single-arm trial1,2

Study Design1,2

Female patients with
HER2+ unresectable
and/or metastatic breast
cancer who had received
two or more prior
anti-HER2 therapies

Established the
recommended
Phase 2 dose (RP2D)

Evaluated safety
and efficacy at RP2D

  • 184 patients received
    ENHERTU 5.4 mg/kg
  • Administered by IV infusion
  • Q3W until unacceptable
    toxicity or disease progression
Primary endpoint1
  • Confirmed objective response rate (ORR), based on RECIST v1.1a
Key secondary endpoints1,2
  • Overall survival (OS), duration of response (DOR), progression-free survival (PFS), disease control rate (DCR), clinical benefit rate (CBR), and best percent change in the sum of diameters of measurable tumorsb

Primary endpoint1

Key secondary endpoints1,2

  • Confirmed objective response rate (ORR), based on RECIST v1.1a
  • Overall survival (OS), duration of response (DOR), progression-free survival (PFS), disease control rate (DCR), clinical benefit rate (CBR), and best percent change in the sum of diameters of measurable tumorsb
Selected exclusion criteria1
  • History of treated interstitial lung disease (ILD) or ILD at screening
  • History of clinically significant cardiac disease
  • Active brain metastasesc
  • ECOG performance status >1

Multiple confirmatory Phase 3 studies are underway3

aORR defined as CR+PR per RECIST v1.1 in the ITT population as evaluated by ICR.1,2 bDCR=CR+PR+SD; CBR=CR+PR+SD≥6 months.2 cPatients with brain metastases who were untreated, symptomatic, or required therapy within 2 months of randomization were excluded. A prespecified number of patients with inactive brain metastases were enrolled.4

In DESTINY-Breast01,

All trial participants had previously received two or more anti-HER2 therapies1

Baseline patient demographics and disease characteristics1,4


DESTINY-Breast01 (N=184)
Age, median 55 years (range: 28-96)
Female 100%
White 55%
Asian 38%
Black/African American 2%
ECOG performance status
at baseline
0 55%
1 44%
Hormone receptor status Positive: 53%
Sum of diameters of target lesionsd <5 cm: 42%, ≥5 cm: 50%
Previous systemic
cancer therapy
Trastuzumab 100%
Pertuzumab 66%
Ado-trastuzumab emtansine (T-DM1) 100%
Prior cancer regimens in locally advanced/metastatic setting, median 5 (range: 2-17)

dNot evaluable by central review in 8% of patients.1

Site of metastases at baseline1,4


DESTINY-Breast01 (N=184)
Presence of visceral disease 92%
Lung metastases 57%
Liver metastases 30%
Bone metastases 29%
Brain metastases 13%
Ready to learn more about ENHERTU?
CR, complete response; DCR, disease control rate; ECOG, Eastern Cooperative Oncology Group; HER2, human epidermal growth factor receptor 2; ICR, independent central review; ITT, intent-to-treat; IV, intravenous; PR, partial response; Q3W, every 3 weeks; RECIST, Response Evaluation Criteria in Solid Tumors; SD, stable disease.