DESTINY-Breast04: Patients Demographics and Baseline Characteristics (January 11, 2022 DCO Date)
Patients Treated by Region1
Patients Treated by Region1
Patients Treated by Region1
Patient Disposition1
Patient Disposition2
Patient Disposition2
aOther includes clinical progression, physician decision, lost to follow-up, and other unknown reasons.
Baseline Characteristics1,3,4
| Characteristic | HR+ | All Patients (HR+ and HR−) | ||
T-DXd (n=331) | TPC (n=163) | T-DXd (n=373) | TPC (n=184) | |
| Age, median, years (range) | 56.8 (31.5-80.2) | 55.7 (28.4-80.0) | 57.5 (31.5-80.2) | 55.9 (28.4-80.5) |
| Female, n (%) | 329 (99.4) | 163 (100) | 371 (99.5) | 184 (100.0) |
| Region, n (%) | ||||
| 149 (45.0) | 73 (44.8) | 166 (44.5) | 85 (46.2) |
| 128 (38.7) | 60 (36.8) | 147 (39.4) | 66 (35.9) |
| 54 (16.3) | 30 (18.4) | 60 (16.1) | 33 (17.9) |
| Race, n (%)12. | ||||
| 156 (47.1) | 78 (47.9) | 176 (47.2) | 91 (49.5) |
| 7 (2.1) | 2 (1.2) | 7 (1.9) | 3 (1.6) |
| 131 (39.6) | 66 (40.5) | 151 (40.5) | 72 (39.1) |
| 37 (11.2) | 0 | 16 (9.8) | 1 (0.6) | 39 (10.5) | 0 | 17 (9.2) | 1 (0.5) |
| Ethnicity, n (%)12. | ||||
| 14 (4.2) | 5 (3.1) | 14 (3.8) | 7 (3.8) |
| 267 (80.7) | 137 (84.0) | 308 (82.6) | 153 (83.2) |
| 9 (2.7) | 4 (2.5) | 9 (2.4) | 7 (3.8) |
| 41 (12.4) | 17 (10.4) | 42 (11.3) | 17 (9.2) |
| HER2-low status, n (%)12. | ||||
| 193 (58.3) | 95 (58.3) | 215 (57.6) | 106 (57.6) |
| 138 (41.7) | 68 (41.7) | 158 (42.4) | 78 (42.4) |
| ECOG PS score, n (%)12. | ||||
| 187 (56.5) | 95 (58.3) | 200 (53.6) | 105 (57.1) |
| 144 (43.5) | 68 (41.7) | 173 (46.4) | 79 (42.9) |
HR+, n (%)12. | 328 (99.1) | 162 (99.4) | 333 (89.3) | 166 (90.2) |
BM at baseline, n (%) | 18 (5.4) | 7 (4.3) | 24 (6.4) | 8 (4.3) |
Liver metastases at baseline, n (%) | 247 (74.6) | 116 (71.2) | 266 (71.3) | 123 (66.8) |
Lung metastases at baseline, n (%) | 98 (29.6) | 58 (35.6) | 120 (32.2) | 63 (34.2) |
Note: Percentages may not total 100 because of rounding. CDK4/6 denotes cyclin-dependent kinases 4 and 6
2Race and ethnic group were reported by the patients. Available options are included in the manuscript supplement; 3Low expression of HER2 was defined as a score of 1+ on IHC analysis or as an IHC score of 2+ and negative results on ISH; 4PS scores on the ECOG scale range from 0 (no disability) to 5 (death); 5For the intent-to-treat analyses with the HR+ cohort, hormone receptor status is based on data collected using the interactive web/voice response system at the time of randomization, which includes patients who were mis-stratified..
Prior Therapies3
| Characteristic | HR+ | All Patients (HR+ and HR−) | ||
T-DXd (n=331) | TPC (n=163) | T-DXd (n=373) | TPC (n=184) | |
| Lines of systemic therapy15. (metastatic setting) | ||||
| Median number of lines (range) | 3 (1-9) | 3 (1-8) | 3 (1-9) | 3 (1-8) |
Number of lines, n (%) | ||||
| 23 (7) | 14 (9) | 39 (10) | 19 (10) |
| 85 (26) | 41 (25) | 100 (27) | 53 (29) |
| 223 (67) | 108 (66) | 234 (63) | 112 (61) |
| Lines of chemotherapy (metastatic setting) | ||||
| Median number of lines (range) | 1 (0-3) | 1 (0-2) | 1 (0-3) | 1 (0-2) |
| Number of lines, n (%) | ||||
| 1 (0.3) | 1 (0.6) | 1 (0.3) | 1 (0.5) |
| 203 (61.3) | 93 (57.1) | 221 (59.2) | 100 (54.3) |
| 124 (37.5) | 69 (42.3) | 145 (38.9) | 83 (45.1) |
| Lines of endocrine therapy (metastatic setting) | ||||
| Median number of lines (range) | 2 (0-7) | 2 (0-6) | 2 (0-7) | 2 (0-6) |
| Number of lines, n (%) | ||||
| 28 (8) | 17 (10) | 60 (16) | 34 (18) |
| 105 (32) | 49 (30) | 108 (29) | 51 (28) |
| 110 (33) | 53 (33) | 115 (31) | 54 (29) |
| 88 (27) | 44 (27) | 90 (24) | 45 (24) |
| Prior targeted cancer therapy, n (%) | ||||
| 259 (78) | 132 (81) | 279 (75) | 140 (76) |
| 233 (70) | 115 (71) | 239 (64) | 119 (65) |
Abbreviations
BM = brain metastases
;CDK4/6i = cyclin-dependent kinase 4/6 inhibitor
;DCO = data cut-off
;ECOG = Eastern Cooperative Oncology Group
;HER2 = human epidermal growth factor receptor 2
;HR = hormone receptor
;IHC = immunohistochemistry
;ISH = in situ hybridization
;PS = performance status
;T-DXd = trastuzumab deruxtecan
;TPC = treatment of physician's choice
References
2. Modi S, Jacot W, Yamashita T, et al. Trastuzumab deruxtecan in previously treated HER2-low advanced breast cancer [supplementary appendix]. N Engl J Med. 2022;387:9-20.
3. Modi S, Jacot W, Yamashita T, et al. Trastuzumab deruxtecan (T-DXd) Vs treatment of physician’s choice in patients with HER2-low unresectable and/or metastatic breast cancer: results of DESTINY-Breast04, a randomized, phase 3 study [abstract and presentation]. Presented at: American Society of Clinical Oncology (ASCO) Congress; June 3-5, 2022; Chicago, IL. J Clin Oncol. 2022;40(suppl 17). Abs LBA3.
4. Ueno N, Jacot W, Yamashita T, et al. Patient-reported outcomes from DESTINY-Breast04, a randomized phase 3 study of trastuzumab deruxtecan (T-DXd) vs treatment of physician’s choice in patients with HER2-low metastatic breast cancer [presentation and supplement]. Presented at: European Society for Medical Oncology (ESMO) 2022; September 9-13, 2022; Paris, France. Ann Oncol. 2022;33(suppl 7). Abs 217O.
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