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NCT03248492 · OUTCOME

Objective Response Rate as Confirmed by Independent Central Review Following Intravenous Administration of 5.4 mg/kg 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

The number of participants with objective response was assessed every six weeks from Cycle 1 Day 1 through discontinuation of treatment, by independent central imaging facility review based on RECIST version 1.1.

Analysis population: Objective response rate (ORR) was assessed in the Enrolled Analysis Set.at data cut-off date of 21 March 2019

Groups in this outcome

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

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

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 and Part 2a: DS-8201a Low Dose180
Part 1 + Part 2a + Part 2b: DS-8201a Low Dose184

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 and Part 2a: DS-8201a Low Dose109Not reportedNot reportedNot reportedNot reported
Part 1 + Part 2a + Part 2b: DS-8201a Low Dose111Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        109
      2. group Id
        OG001
        value
        111
denoms
  1. counts
    1. group Id
      OG000
      value
      180
    2. group Id
      OG001
      value
      184
    units
    Participants
description
The number of participants with objective response was assessed every six weeks from Cycle 1 Day 1 through discontinuation of treatment, by independent central imaging facility review based on RECIST version 1.1.
groups
  1. description
    All T-DM1 resistant/refractory (R/R) participants who were treated in Part 1 or Part 2a at the recommended (5.4 mg/kg) dose.
    id
    OG000
    title
    Part 1 and Part 2a: DS-8201a Low Dose
  2. 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
    OG001
    title
    Part 1 + Part 2a + Part 2b: DS-8201a Low Dose
param Type
COUNT_OF_PARTICIPANTS
population Description
Objective response rate (ORR) 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
Objective Response Rate as Confirmed by Independent Central Review Following Intravenous Administration of 5.4 mg/kg DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice