DESTINY-Breast08: Patient Demographics (Results from Part 1 Modules 4 [T-DXd + Anastrozole] and 5 [T-DXd + Fulvestrant] as of January 20, 2022 DCO)
Patients1
- As of DCO on January 20, 2022, 6 patients were allocated to Module 4 and received the initial dose level of T-DXd 5.4 mg/kg IV Q3W + anastrozole 1 mg orally taken once a day and 6 patients were allocated to Module 5 and received the initial dose level of T-DXd 5.4 mg/kg IV Q3W plus fulvestrant 500 mg IM Q4W (loading dose of 500 mg on C1D15).
- Of the 6 patients allocated to Module 4, 3 are ongoing treatment while 3 have discontinued both study drugs. Two patients discontinued due to objective disease progression (33.3%) and 1 patient discontinued due to clinical disease progression (16.7%).
- Of the 6 patients allocated to Module 5, 5 patients are ongoing treatment and only 1 discontinued treatment with T-DXd due to an AE of pneumonitis and with fulvestrant due to objective disease progression.
Patient Demographics (Results from Part 1 Modules 4 [T-DXd + Anastrozole] and 5 [T-DXd + Fulvestrant] as of January 20, 2022 DCO)1
| Characteristics | Module 4 T-DXd + Anastrozole n=6 | Module 5 T-DXd + Fulvestrant n=6 |
| Age, mean (range), years | 57.7 (47-71) | 59.0 (46-74) |
| Female, n (%) | 6 (100) | 6 (100) |
Race, n (%) Asian White |
6 (100) 0 |
4 (66.7) 2 (33.3) |
Primary tumor location, n (%) Breast |
6 (100) |
6 (100) |
HER2 score, n (%) IHC 2+/ISH - IHC 1+ |
3 (50.0) 3 (50.0) |
4 (66.7) 2 (33.3) |
ECOG PS, n (%) 0 1 |
5 (83.3) 1 (16.7) |
4 (66.7) 2 (33.3) |
Abbreviations
AE = adverse event
;ECOG = Eastern Cooperative Oncology Group
;DCO = data cut-off
;HER2 = human epidermal growth factor receptor 2
;IHC = immunohistochemistry
;IM = intramuscular
;IV = intravenous
;ISH = in situ hybridization
;PS = performance status
;Q3W = every 3 weeks
;Q4W = every 4 weeks
;T-DXd = trastuzumab deruxtecan
References
Document ID: 1592ad62-13a7-4b16-87ee-22c395bd8a67
Last updated: 09-December-2022
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