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NCT02614794 · OUTCOME

Clinical Benefit Rate (CBR) as Determined by BICR Per RECIST 1.1

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

Clinical benefit was defined as achieving stable disease (SD) or non-complete response (CR)/non-progressive disease (PD) for at least 6 months or a best overall response of confirmed CR or confirmed partial response (PR).

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 percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra59.8Not reported54.864.5Not reported
Pbo+Cap+Tra38.1Not reported31.445.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        54.8
        upper Limit
        64.5
        value
        59.8
      2. group Id
        OG001
        lower Limit
        31.4
        upper Limit
        45.2
        value
        38.1
denoms
  1. counts
    1. group Id
      OG000
      value
      410
    2. group Id
      OG001
      value
      202
    units
    Participants
description
Clinical benefit was defined as achieving stable disease (SD) or non-complete response (CR)/non-progressive disease (PD) for at least 6 months or a best overall response of confirmed CR or confirmed partial response (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-OS Population: Includes all randomized participants evaluated by their randomized treatment assignment.
reporting Status
POSTED
time Frame
34.6 months
title
Clinical Benefit Rate (CBR) as Determined by BICR Per RECIST 1.1
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice