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NCT02614794 · OUTCOME

PFS Per RECIST 1.1 as Determined by Investigator Assessment at Time of Primary Analysis

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
34.6 months

What was measured

Defined as the time from the date of randomization to the date of documented disease progression

Analysis population: ITT-PFS Population: Includes the first 480 randomized participants in the ITT analysis population (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+Tra320
Pbo+Cap+Tra160

Reported measurements

Source class 1
Values in months · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra7.5Not reported4.113.1Not reported
Pbo+Cap+Tra4.3Not reported2.78.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.1
        upper Limit
        13.1
        value
        7.5
      2. group Id
        OG001
        lower Limit
        2.7
        upper Limit
        8.4
        value
        4.3
denoms
  1. counts
    1. group Id
      OG000
      value
      320
    2. group Id
      OG001
      value
      160
    units
    Participants
description
Defined as the time from the date of randomization to the date of documented disease progression
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-PFS Population: Includes the first 480 randomized participants in the ITT analysis population (evaluated by their randomized treatment assignment).
reporting Status
POSTED
time Frame
34.6 months
title
PFS Per RECIST 1.1 as Determined by Investigator Assessment at Time of Primary Analysis
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice