Baseline characteristics

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.

denoms

1. counts

   1. group Id

      BG000

      value

      365

   2. group Id

      BG001

      value

      367

   3. group Id

      BG002

      value

      732

   units

   Participants

groups

1. description

   Arm 1: Dato-DXd

   id

   BG000

   title

   Dato-DXd

2. description

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

   id

   BG001

   title

   Investigator's Choice of Chemotherapy (ICC)

3. description

   Total of all reporting groups

   id

   BG002

   title

   Total

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            lower Limit

            29

            upper Limit

            86

            value

            56.0

         2. group Id

            BG001

            lower Limit

            28

            upper Limit

            86

            value

            54.0

         3. group Id

            BG002

            lower Limit

            28

            upper Limit

            86

            value

            55.0

   dispersion Type

   FULL_RANGE

   param Type

   MEDIAN

   title

   Age, Continuous

   unit Of Measure

   Years

2. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            360

         2. group Id

            BG001

            value

            363

         3. group Id

            BG002

            value

            723

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            5

         2. group Id

            BG001

            value

            4

         3. group Id

            BG002

            value

            9

         title

         Male

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Sex: Female, Male

   unit Of Measure

   Participants

3. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            40

         2. group Id

            BG001

            value

            43

         3. group Id

            BG002

            value

            83

         title

         Hispanic or Latino

      2. measurements

         1. group Id

            BG000

            value

            322

         2. group Id

            BG001

            value

            318

         3. group Id

            BG002

            value

            640

         title

         Not Hispanic or Latino

      3. measurements

         1. group Id

            BG000

            value

            3

         2. group Id

            BG001

            value

            6

         3. group Id

            BG002

            value

            9

         title

         Unknown or Not Reported

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Ethnicity (NIH/OMB)

   unit Of Measure

   Participants

4. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            4

         2. group Id

            BG001

            value

            7

         3. group Id

            BG002

            value

            11

         title

         Black or African American

      2. measurements

         1. group Id

            BG000

            value

            0

         2. group Id

            BG001

            value

            0

         3. group Id

            BG002

            value

            0

         title

         Native Hawaiian or other Pacific Islander

      3. measurements

         1. group Id

            BG000

            value

            0

         2. group Id

            BG001

            value

            0

         3. group Id

            BG002

            value

            0

         title

         American Indian or Alaska Native

      4. measurements

         1. group Id

            BG000

            value

            146

         2. group Id

            BG001

            value

            152

         3. group Id

            BG002

            value

            298

         title

         Asian

      5. measurements

         1. group Id

            BG000

            value

            180

         2. group Id

            BG001

            value

            170

         3. group Id

            BG002

            value

            350

         title

         White

      6. measurements

         1. group Id

            BG000

            value

            3

         2. group Id

            BG001

            value

            6

         3. group Id

            BG002

            value

            9

         title

         Other

      7. measurements

         1. group Id

            BG000

            value

            32

         2. group Id

            BG001

            value

            32

         3. group Id

            BG002

            value

            64

         title

         Not reported

   description

   Race

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Race/Ethnicity, Customized

   unit Of Measure

   Participants

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Preserved source evidence · Not medical advice