Participant flow

A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1) · Source last updated 2025-06-26

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

groups

1. description

   T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a low dose (5.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.

   id

   FG000

   title

   Part 1: DS-8201a Low Dose

2. description

   T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.

   id

   FG001

   title

   Part 1: DS-8201a Medium Dose

3. description

   T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phase.

   id

   FG002

   title

   Part 1: DS-8201a High Dose

4. description

   All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 2a in the continuation phase.

   id

   FG003

   title

   Part 2a: DS-8201a Low Dose

5. description

   All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 2b in the continuation phase.

   id

   FG004

   title

   Part 2b (Exploratory): DS-8201a Low Dose

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         24

      2. group Id

         FG001

         num Subjects

         23

      3. group Id

         FG002

         num Subjects

         11

      4. group Id

         FG003

         num Subjects

         66

      5. group Id

         FG004

         num Subjects

         1

      type

      Progressive Disease

   2. reasons

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         13

      3. group Id

         FG002

         num Subjects

         9

      4. group Id

         FG003

         num Subjects

         22

      5. group Id

         FG004

         num Subjects

         2

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         8

      5. group Id

         FG004

         num Subjects

         1

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         7

      5. group Id

         FG004

         num Subjects

         0

      type

      Physician Decision

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         6

      5. group Id

         FG004

         num Subjects

         0

      type

      Death

   6. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         7

      5. group Id

         FG004

         num Subjects

         0

      type

      Study Terminated by Sponsor

   7. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         5

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         14

      5. group Id

         FG004

         num Subjects

         0

      type

      Other

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         50

      2. group Id

         FG001

         num Subjects

         48

      3. group Id

         FG002

         num Subjects

         21

      4. group Id

         FG003

         num Subjects

         130

      5. group Id

         FG004

         num Subjects

         4

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         50

      2. group Id

         FG001

         num Subjects

         48

      3. group Id

         FG002

         num Subjects

         21

      4. group Id

         FG003

         num Subjects

         130

      5. group Id

         FG004

         num Subjects

         4

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

In Part 1, participants were randomized 1:1:1 to either 5.4 mg/kg, 6.4 mg/kg, or 7.4 mg/kg dose of DS-8201a. Two doses randomized 1:1 (5.4 or 6.4 mg/kg) were further evaluated. In Part 2, all T-DM1 resistant refractory participants (cohort 2a) or T-DM1 intolerant (cohort 2b) received DS-8201a at the recommended dose.

recruitment Details

Participants who met all of the inclusion and none of the exclusion criteria were enrolled and randomized to treatment (Part 1) or received DS-8201a at the recommended dose (Part 2).

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Preserved source evidence · Not medical advice