TROPION-BREAST01 EFFICACYTROPION-BREAST01

DATROWAY was studied in a global, phase 3 trial for 2L+ HR+/HER2− mBC^1,2

Study design
Baseline characteristics

TROPION-Breast01 was a randomized, open-label trial

Dual primary endpoints^a: PFS (BICR), OS

SELECT SECONDARY ENDPOINTS: ORR, DCR, DoR, safety

ELIGIBILITY CRITERIA

Unresectable or metastatic HR+/HER2− breast cancer^b (IHC 0, IHC 1+ or IHC 2+/ISH−)
Previously treated with 1 or 2 lines of chemotherapy in unresectable/metastatic setting^c

Progressed on and not suitable for further ET
ECOG PS 0 or 1

STRATIFICATION FACTORS

1 or 2 lines of chemotherapy in unresectable/metastatic setting

Previous CDK4/6 inhibitor use
Geography

732 patients were randomized 1:1 to receive either DATROWAY® or physician’s choice of chemotherapy

DATROWAY, 6 mg/kg IV Q3W (n=365)

Investigator’s choice of chemotherapy^d (n=367)

[eribulin, capecitabine, vinorelbine, gemcitabine]

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

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

^bPer American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines.²

^cNo prior ADC use was permitted.²

^dInvestigator'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

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^e		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^f	96	98
	Liver metastases	75	68
	Stable brain metastases	10	6
Prior endocrine therapy, %^g
Prior endocrine therapy, %^g	Unresectable/metastatic setting	88	89
Prior lines of chemotherapy, %^h	1	63	61
Prior lines of chemotherapy, %^h	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=365)
Age, median (range), years^e	54 (28-86)	54 (26–86)
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^f	96	98
Liver metastases	75	68
Stable brain metastases	10	6
Prior endocrine therapy, %^g
Unresectable/metastatic setting	88	89
Prior lines of chemotherapy, %^h
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

^eOf patients treated with DATROWAY, 25% were ≥65 and 5% were ≥75 years of age.¹

^fVisceral metastases includes all sites except bone.⁶

^g95% of patients in the DATROWAY arm and 96% in the chemotherapy arm had received any prior hormonal therapy, including the adjuvant setting.²

^hOne 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

DATROWAY was studied in a global, phase 3 trial for 2L+ HR+/HER2− mBC1,2

TROPION-Breast01 was a randomized, open-label trial

DATROWAY was studied in a global, phase 3 trial for 2L+ HR+/HER2− mBC^1,2