DATROWAY was studied in a global phase 3 trial for adults with HR+/HER2– mBC post ET and chemotherapy^1,2

TROPION-Breast01 was a randomized, open-label trial

ELIGIBILITY CRITERIA

Unresectable or metastatic HR+/HER2− breast cancer* (IHC 0, IHC 1+ or IHC 2+/ISH–)

Previously treated with 1 or 2 lines of chemotherapy in unresectable/metastatic setting^†

Progressed on and deemed not suitable for further ET

ECOG PS 0 or 1

N=732

1:1

DATROWAY

6 mg/kg IV Q3W

until disease progression or unacceptable toxicity

(n=365)

Investigator's choice of chemotherapy‡

[eribulin, capecitabine, vinorelbine, gemcitabine]
until disease progression or unacceptable toxicity

(n=367)

DUAL PRIMARY ENDPOINTS^§:

PFS (BICR), OS

SELECT SECONDARY ENDPOINTS:

ORR, DCR, DoR, safety

STRATIFICATION FACTORS

1 or 2 lines of chemotherapy in unresectable/metastatic setting

Previous CDK4/6 inhibitor use

Geography

Trop-2 testing not required for DATROWAY.¹

During the study, ADCs were approved for use in HR+/HER2– mBC.

After treatment discontinuation, some patients in both arms received subsequent ADC therapy^2-4

*Per American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines.²

^†No prior ADC use was permitted.²

^‡Investigator's choice of chemotherapy (ICC) was administered as follows: eribulin 1.4 mg/m² IV on Days 1 and 8, Q3W; capecitabine, 1000 or 1250 mg/m² orally twice daily on Days 1 to 14, Q3W; vinorelbine, 25 mg/m² IV on Days 1 and 8, Q3W; or gemcitabine, 1000 mg/m² IV on Days 1 and 8, Q3W.²

^§The study was considered positive if either the PFS analysis results or the OS analysis results were statistically significant.^1,5

TROPION-Breast01 was a global trial and included patients often seen in clinical practice^1,2,6,7

Baseline characteristics		DATROWAY (n=365)	Chemotherapy (n=367)
Age, median (range), years*		56 (29-86)	54 (28-86)
Sex, %	Female	99	99
Race, %	White	49	46
	Asian	40	41
	Black or African American	1	2
Ethnicity, %	Hispanic/Latino	11	12
Ethnicity, %	Not Hispanic or Latino	88	87
ECOG performance status, %	0	54	60
ECOG performance status, %	1	45	40
Sites of metastases at study entry, %	Visceral disease^†	96	98
	Liver metastases	75	68
	Stable brain metastases	10	6
Prior endocrine therapy, %^‡	Unresectable/metastatic setting	88	89
Prior lines of chemotherapy, %^§	1	63	61
Prior lines of chemotherapy, %^§	2	37	38
Prior taxanes or anthracyclines, %	Taxanes	81	81
Prior taxanes or anthracyclines, %	Anthracyclines	63	65
Prior CDK4/6 inhibitor, %	Yes	83	82
Prior CDK4/6 inhibitor, %	No	17	18

Baseline characteristics	DATROWAY (n=365)	Chemotherapy (n=367)
Age, median (range), years*	56 (29-86)	57 (28-86)
Sex, %
Female	99	99
Race, %
White	49	46
Asian	40	41
Black or African American	1	2
Ethnicity, %
Hispanic/Latino	11	12
Not Hispanic or Latino	88	87
ECOG performance status, %
0	54	60
1	45	40
Sites of metastases at study entry, %
Visceral disease^†	96	98
Liver metastases	75	68
Stable brain metastases	10	6
Prior endocrine therapy, %^‡
Unresectable/metastatic setting	88	89
Prior lines of chemotherapy, %^§
1	63	61
2	37	38
Prior taxanes or anthracyclines, %
Taxanes	81	81
Anthracyclines	63	65
Prior CDK4/6 inhibitor, %
Yes	83	82
No	17	18

*Of patients treated with DATROWAY, 23% were ≥65 and 5% were ≥75 years of age.¹

^†Visceral metastases includes all sites except bone.⁶

^‡95% of patients in the DATROWAY arm and 96% in the chemotherapy arm had received any prior hormonal therapy, including the adjuvant setting.²

^§One patient in the DATROWAY arm had received three previous lines of chemotherapy and one patient in the chemotherapy arm had received four previous lines of chemotherapy.²

ADC, antibody-drug conjugate; ALT, alanine aminotransferase; AR, adverse reaction; AST, aspartate aminotransferase; BICR, blinded independent central review; CDK, cyclin-dependent kinase; CI, confidence interval; ET, endocrine therapy; HER2−, human epidermal growth factor receptor 2-negative; HR, hazard ratio; HR+, hormone receptor-positive; IV, intravenous; mBC, metastatic breast cancer; mPFS, median progression-free survival; OS, overall survival; PFS, progression-free survival; Q3W, once every three weeks; TRAE, treatment-related adverse event; Trop-2, trophoblast cell-surface antigen 2.

ADC, antibody-drug conjugate; BICR, blinded independent central review; CDK, cyclin-dependent kinase; DCR, disease control rate; DoR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; ET, endocrine therapy; HER2–, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive; IHC, immunohistochemistry; ISH, in situ hybridization; IV, intravenous; mBC, metastatic breast cancer; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; Q3W, once every three weeks; Trop-2, trophoblast cell-surface antigen 2.

BICR, blinded independent central review; CDK, cyclin-dependent kinase; Cl, confidence interval; CR, complete response; DCR, disease control rate; DoR, duration of response; ECOG, Eastern Cooperative Oncology Group; ET, endocrine therapy; HER2−, human epidermal growth factor receptor 2-negative; HR, hazard ratio; HR+, hormone receptor-positive; mBC, metastatic breast cancer; mOS, median overall survival; mPFS, median progression-free survival; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors; SD, stable disease.

ADC, antibody-drug conjugate; ALT, alanine aminotransferase; AR, adverse reaction; AST, aspartate aminotransferase; COVID-19, coronavirus disease 2019; G-CSF, granulocyte-colony stimulating factor; HER2−, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive; IHC, immunohistochemistry; ILD, interstitial lung disease; ISH, in situ hybridization; NCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; Q3W, once every three weeks; TRAE, treatment-related adverse event; Trop-2, trophoblast cell-surface antigen 2.

ADC, antibody-drug conjugate; HER2−, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive; IHC, immunohistochemistry; ISH, in situ hybridization; IV, intravenous; Q3W, once every three weeks; Trop-2, trophoblast cell-surface antigen 2.

5-HT3, 5-hydroxytryptamine type 3; HER2−, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive; ILD, interstitial lung disease; Trop-2, trophoblast cell-surface antigen 2.

DNA, deoxyribonucleic acid; HER2−, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive; mAb, monoclonal antibody; Trop-2, trophoblast cell-surface antigen 2.

HER2−, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive.

DATROWAY was studied in a global phase 3 trial for adults with HR+/HER2– mBC post ET and chemotherapy1,2