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NCT02614794 · OUTCOME

ORR 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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
34.6 months

What was measured

Defined as achieving a best overall response of confirmed CR or confirmed PR.

Analysis population: ITT - PFS population, subset of participants with measurable disease by investigator at baseline. The 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+Tra280
Pbo+Cap+Tra139

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra41.4Not reported35.647.4Not reported
Pbo+Cap+Tra23.0Not reported16.330.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        35.6
        upper Limit
        47.4
        value
        41.4
      2. group Id
        OG001
        lower Limit
        16.3
        upper Limit
        30.9
        value
        23.0
denoms
  1. counts
    1. group Id
      OG000
      value
      280
    2. group Id
      OG001
      value
      139
    units
    Participants
description
Defined as achieving a best overall response of confirmed CR or confirmed PR.
dispersion Type
95% Confidence Interval
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
NUMBER
population Description
ITT - PFS population, subset of participants with measurable disease by investigator at baseline. The 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
ORR Per RECIST 1.1 as Determined by Investigator Assessment
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice