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NCT02614794 · OUTCOME

DOR Per RECIST 1.1 as Determined by Investigator Assessment

A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer · Source last updated 2023-08-14

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

Measure
MEDIAN
Unit
months
Interval / dispersion
Inter-Quartile Range
Time frame
33.2 months

What was measured

Defined as the time from the first objective response to documented disease progression or death from any cause, whichever occurred first.

Analysis population: ITT-OS Population: Includes all randomized participants evaluated by their randomized treatment assignment.

Groups in this outcome

Tuc+Cap+Tra

Tucatinib in combination with capecitabine \& trastuzumab

Pbo+Cap+Tra

Placebo in combination with capecitabine \& trastuzumab

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

Analysis denominator · Participants

GroupSource count
Tuc+Cap+Tra410
Pbo+Cap+Tra202

Reported measurements

Source class 1
Values in months · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra7.0Not reported4.312.9Not reported
Pbo+Cap+Tra6.9Not reported4.19.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.3
        upper Limit
        12.9
        value
        7.0
      2. group Id
        OG001
        lower Limit
        4.1
        upper Limit
        9.6
        value
        6.9
denoms
  1. counts
    1. group Id
      OG000
      value
      410
    2. group Id
      OG001
      value
      202
    units
    Participants
description
Defined as the time from the first objective response to documented disease progression or death from any cause, whichever occurred first.
dispersion Type
Inter-Quartile Range
groups
  1. description
    Tucatinib in combination with capecitabine \& trastuzumab
    id
    OG000
    title
    Tuc+Cap+Tra
  2. description
    Placebo in combination with capecitabine \& trastuzumab
    id
    OG001
    title
    Pbo+Cap+Tra
param Type
MEDIAN
population Description
ITT-OS Population: Includes all randomized participants evaluated by their randomized treatment assignment.
reporting Status
POSTED
time Frame
33.2 months
title
DOR Per RECIST 1.1 as Determined by Investigator Assessment
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice