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NCT03248492 · OUTCOME

Best Overall Tumor Response as Confirmed By the Investigator Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)

What was measured

Best overall tumor response was defined as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) by the investigator based on RECIST v1.1. Participants who were non-evaluable (NE) are also reported.

Analysis population: Best overall tumor response was assessed in the Enrolled Analysis Set at data cut-off date of 21 March 2019.

Groups in this outcome

Part 1: DS-8201a Medium Dose

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.

Part 1: DS-8201a High Dose

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 phases.

Part 1 + Part 2a: DS-8201a Low Dose

All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 1 or Part 2a.

Part 1 + Part 2a + Part 2b: DS-8201a Low Dose

All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 1 or Part 2a or Part 2b.

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

Analysis denominator · Participants

GroupSource count
Part 1: DS-8201a Medium Dose48
Part 1: DS-8201a High Dose21
Part 1 + Part 2a: DS-8201a Low Dose180
Part 1 + Part 2a + Part 2b: DS-8201a Low Dose184

Reported measurements

Complete response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: DS-8201a Medium Dose3Not reportedNot reportedNot reportedNot reported
Part 1: DS-8201a High Dose0Not reportedNot reportedNot reportedNot reported
Part 1 + Part 2a: DS-8201a Low Dose4Not reportedNot reportedNot reportedNot reported
Part 1 + Part 2a + Part 2b: DS-8201a Low Dose6Not reportedNot reportedNot reportedNot reported
Partial response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: DS-8201a Medium Dose34Not reportedNot reportedNot reportedNot reported
Part 1: DS-8201a High Dose18Not reportedNot reportedNot reportedNot reported
Part 1 + Part 2a: DS-8201a Low Dose112Not reportedNot reportedNot reportedNot reported
Part 1 + Part 2a + Part 2b: DS-8201a Low Dose112Not reportedNot reportedNot reportedNot reported
Stable disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: DS-8201a Medium Dose10Not reportedNot reportedNot reportedNot reported
Part 1: DS-8201a High Dose3Not reportedNot reportedNot reportedNot reported
Part 1 + Part 2a: DS-8201a Low Dose59Not reportedNot reportedNot reportedNot reported
Part 1 + Part 2a + Part 2b: DS-8201a Low Dose61Not reportedNot reportedNot reportedNot reported
Progressive disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: DS-8201a Medium Dose0Not reportedNot reportedNot reportedNot reported
Part 1: DS-8201a High Dose0Not reportedNot reportedNot reportedNot reported
Part 1 + Part 2a: DS-8201a Low Dose4Not reportedNot reportedNot reportedNot reported
Part 1 + Part 2a + Part 2b: DS-8201a Low Dose4Not reportedNot reportedNot reportedNot reported
Non-evaluable
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: DS-8201a Medium Dose1Not reportedNot reportedNot reportedNot reported
Part 1: DS-8201a High Dose0Not reportedNot reportedNot reportedNot reported
Part 1 + Part 2a: DS-8201a Low Dose1Not reportedNot reportedNot reportedNot reported
Part 1 + Part 2a + Part 2b: DS-8201a Low Dose1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        6
    title
    Complete response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        34
      2. group Id
        OG001
        value
        18
      3. group Id
        OG002
        value
        112
      4. group Id
        OG003
        value
        112
    title
    Partial response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        59
      4. group Id
        OG003
        value
        61
    title
    Stable disease
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        4
    title
    Progressive disease
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
    title
    Non-evaluable
denoms
  1. counts
    1. group Id
      OG000
      value
      48
    2. group Id
      OG001
      value
      21
    3. group Id
      OG002
      value
      180
    4. group Id
      OG003
      value
      184
    units
    Participants
description
Best overall tumor response was defined as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) by the investigator based on RECIST v1.1. Participants who were non-evaluable (NE) are also reported.
groups
  1. 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
    OG000
    title
    Part 1: DS-8201a Medium Dose
  2. 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 phases.
    id
    OG001
    title
    Part 1: DS-8201a High Dose
  3. description
    All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 1 or Part 2a.
    id
    OG002
    title
    Part 1 + Part 2a: DS-8201a Low Dose
  4. description
    All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 1 or Part 2a or Part 2b.
    id
    OG003
    title
    Part 1 + Part 2a + Part 2b: DS-8201a Low Dose
param Type
COUNT_OF_PARTICIPANTS
population Description
Best overall tumor response was assessed in the Enrolled Analysis Set at data cut-off date of 21 March 2019.
reporting Status
POSTED
time Frame
at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)
title
Best Overall Tumor Response as Confirmed By the Investigator Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice