NCT05104866 · OUTCOME

Disease Control Rate (DCR)

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: Assessed up to data cut-off (17Jul2023) to a maximum of 21 months for BICR assessment and assessed up to data cut-off (24Jul2024) to a maximum of 33 months for investigator assessment.

What was measured

DCR is defined as the percentage of participants who have a confirmed CR or PR up to data cut-off date or who have SD for at least 11 weeks after randomization, per RECIST 1.1, as assessed BICR/per investigator assessment and derived from the raw tumor data.

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

Response by BICR assessment based on IA1 data cut-off Raw disease control rate (%)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dato-DXd	75.34	Not reported	70.59	79.68	Not reported
Investigator's Choice of Chemotherapy (ICC)	63.76	Not reported	58.61	68.69	Not reported

Response by investigator assessment based on FA data cut-off Raw disease control rate (%)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dato-DXd	80.82	Not reported	76.40	84.73	Not reported
Investigator's Choice of Chemotherapy (ICC)	66.76	Not reported	61.68	71.56	Not reported

Source statistical analyses

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

ci Lower Limit
1.27
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.42
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
0.0006
param Type
Odds Ratio (OR)
param Value
1.75
statistical Comment
Performed using a logistic regression model with factors for treatment and the stratification factors.
statistical Method
Regression, Logistic
ci Lower Limit
1.51
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
3.00
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
2.12
statistical Comment
Performed using a logistic regression model with factors for treatment and the stratification factors.
statistical Method
Regression, Logistic
ci Lower Limit
4.93
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
18.16
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 disease control rate
param Value
11.58
ci Lower Limit
7.74
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
20.33
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 disease control rate
param Value
14.06

Complete source fields

analyses

ci Lower Limit
1.27
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.42
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
0.0006
param Type
Odds Ratio (OR)
param Value
1.75
statistical Comment
Performed using a logistic regression model with factors for treatment and the stratification factors.
statistical Method
Regression, Logistic
ci Lower Limit
1.51
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
3.00
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
2.12
statistical Comment
Performed using a logistic regression model with factors for treatment and the stratification factors.
statistical Method
Regression, Logistic
ci Lower Limit
4.93
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
18.16
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 disease control rate
param Value
11.58
ci Lower Limit
7.74
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
20.33
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 disease control rate
param Value
14.06

classes

categories
measurements
group Id
OG000
lower Limit
70.59
upper Limit
79.68
value
75.34
group Id
OG001
lower Limit
58.61
upper Limit
68.69
value
63.76
title
Response by BICR assessment based on IA1 data cut-off Raw disease control rate (%)
categories
measurements
group Id
OG000
lower Limit
76.40
upper Limit
84.73
value
80.82
group Id
OG001
lower Limit
61.68
upper Limit
71.56
value
66.76
title
Response by investigator assessment based on FA data cut-off Raw disease control rate (%)

denoms

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

description

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

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

title

Disease Control Rate (DCR)

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice