NCT05104866 · OUTCOME

Objective Response Rate (ORR)

A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01) · Source last updated 2026-08-24

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: percentage of participants
Interval / dispersion: Not reported
Time frame: From date of randomization until event. Assessed up to data cut-off (17Jul2023) to a maximum of approximately 21 months for BICR assessment and assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months for investigator assessment.

What was measured

Objective response rate is defined as the proportion of participants who have a confirmed CR or PR, as determined by the BICR/Investigator assessment, per RECIST 1.1.

Groups in this outcome

Dato-DXd

Arm 1: Dato-DXd

Investigator's Choice of Chemotherapy (ICC)

Arm 2: ICC (Capecitabine or Gemcitabine or Eribulin mesylate or Vinorelbine)

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Dato-DXd	365
Investigator's Choice of Chemotherapy (ICC)	367

Reported measurements

Confirmed response by BICR assessment based on IA1 data cut-off Raw Response Rate (%)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dato-DXd	36.44	Not reported	31.49	41.61	Not reported
Investigator's Choice of Chemotherapy (ICC)	22.89	Not reported	18.69	27.53	Not reported

Confirmed response by investigator assessment based on FA data cut-off Raw Response Rate (%)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dato-DXd	36.71	Not reported	31.76	41.89	Not reported
Investigator's Choice of Chemotherapy (ICC)	22.07	Not reported	17.93	26.67	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
1.41
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.71
estimate Comment
An odds ratio \> 1 favours Dato-DXd
group Description
Dato-DXd versus ICC based on confirmed response by BICR assessment based on IA1 data cut-off
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.0001
param Type
Odds Ratio (OR)
param Value
1.95
statistical Comment
Performed using a logistic regression model with factors for treatment and the stratification factors.
statistical Method
Regression, Logistic
ci Lower Limit
1.49
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.87
estimate Comment
An odds ratio \> 1 favours Dato-DXd
group Description
Dato-DXd versus ICC based on confirmed response by investigator assessment based on FA data cut-off
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.0001
param Type
Odds Ratio (OR)
param Value
2.06
statistical Comment
Performed using a logistic regression model with factors for treatment and the stratification factors.
statistical Method
Regression, Logistic
ci Lower Limit
6.96
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
20.05
estimate Comment
A positive difference in response rates favours Dato-DXd. Calculated using the Miettinen-Nurminen method.
group Description
Dato-DXd versus ICC based on confirmed response by BICR assessment based on IA1 data cut-off
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
param Type
Difference in raw response rate
param Value
13.55
ci Lower Limit
8.08
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
21.11
estimate Comment
A positive difference in response rates favours Dato-DXd. Calculated using the Miettinen-Nurminen method.
group Description
Dato-DXd versus ICC based on confirmed response by investigator assessment based on FA data cut-off
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
param Type
Difference in raw response rate
param Value
14.64

Complete source fields

analyses

ci Lower Limit
1.41
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.71
estimate Comment
An odds ratio \> 1 favours Dato-DXd
group Description
Dato-DXd versus ICC based on confirmed response by BICR assessment based on IA1 data cut-off
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.0001
param Type
Odds Ratio (OR)
param Value
1.95
statistical Comment
Performed using a logistic regression model with factors for treatment and the stratification factors.
statistical Method
Regression, Logistic
ci Lower Limit
1.49
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.87
estimate Comment
An odds ratio \> 1 favours Dato-DXd
group Description
Dato-DXd versus ICC based on confirmed response by investigator assessment based on FA data cut-off
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.0001
param Type
Odds Ratio (OR)
param Value
2.06
statistical Comment
Performed using a logistic regression model with factors for treatment and the stratification factors.
statistical Method
Regression, Logistic
ci Lower Limit
6.96
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
20.05
estimate Comment
A positive difference in response rates favours Dato-DXd. Calculated using the Miettinen-Nurminen method.
group Description
Dato-DXd versus ICC based on confirmed response by BICR assessment based on IA1 data cut-off
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
param Type
Difference in raw response rate
param Value
13.55
ci Lower Limit
8.08
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
21.11
estimate Comment
A positive difference in response rates favours Dato-DXd. Calculated using the Miettinen-Nurminen method.
group Description
Dato-DXd versus ICC based on confirmed response by investigator assessment based on FA data cut-off
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
param Type
Difference in raw response rate
param Value
14.64

classes

categories
measurements
group Id
OG000
lower Limit
31.49
upper Limit
41.61
value
36.44
group Id
OG001
lower Limit
18.69
upper Limit
27.53
value
22.89
title
Confirmed response by BICR assessment based on IA1 data cut-off Raw Response Rate (%)
categories
measurements
group Id
OG000
lower Limit
31.76
upper Limit
41.89
value
36.71
group Id
OG001
lower Limit
17.93
upper Limit
26.67
value
22.07
title
Confirmed response by investigator assessment based on FA data cut-off Raw Response Rate (%)

denoms

counts
group Id
OG000
value
365
group Id
OG001
value
367
units
Participants

description

Objective response rate is defined as the proportion of participants who have a confirmed CR or PR, as determined by the BICR/Investigator assessment, per RECIST 1.1.

groups

description
Arm 1: Dato-DXd
id
OG000
title
Dato-DXd
description
Arm 2: ICC (Capecitabine or Gemcitabine or Eribulin mesylate or Vinorelbine)
id
OG001
title
Investigator's Choice of Chemotherapy (ICC)

param Type

NUMBER

reporting Status

POSTED

time Frame

From date of randomization until event. Assessed up to data cut-off (17Jul2023) to a maximum of approximately 21 months for BICR assessment and assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months for investigator assessment.

title

Objective Response Rate (ORR)

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice