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NCT05132582 · OUTCOME

Trough Concentration (Ctrough) of Tucatinib

A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer · Source last updated 2026-09-29

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

Measure
GEOMETRIC_MEAN
Unit
nanograms per milliliter
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Pre-dose on Day 1 of Cycles 2, 3, 4, 5 and 6

What was measured

Concentration at Trough was defined as predose/trough concentration observed directly from data.

Analysis population: PK analysis set included all randomized participants who received at least one dose of tucatinib and had at least one evaluable PK assessment. Results were not reported for placebo+Trastuzumab+Pertuzumab arm as more than 50% of concentrations were below the lower limit of quantification(as expected) as prespecified in statistical analysis plan. Overall number of participants analyzed=participants evaluable for this outcome measure. Number Analyzed=participants evaluable for specified rows.

Groups in this outcome

Tucatinib + Trastuzumab + Pertuzumab

Participants with locally advanced HER2+/ mBC were allocated to receive tucatinib 300 mg PO BID with trastuzumab 6 mg/kg IV or at a fixed dose of 600 mg SC, and pertuzumab 420 mg IV once every 21 days. Participants may also have received a fixed dose combination of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase SC, once every 21 days. Participants received study treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.

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

Analysis denominator · Participants

GroupSource count
Tucatinib + Trastuzumab + Pertuzumab321

Reported measurements

Cycle 2

Analysis denominator · Participants

GroupSource count
Tucatinib + Trastuzumab + Pertuzumab166
Values in nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Tucatinib + Trastuzumab + Pertuzumab151.83180.04Not reportedNot reportedNot reported
Cycle 3

Analysis denominator · Participants

GroupSource count
Tucatinib + Trastuzumab + Pertuzumab159
Values in nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Tucatinib + Trastuzumab + Pertuzumab158.63144.77Not reportedNot reportedNot reported
Cycle 4

Analysis denominator · Participants

GroupSource count
Tucatinib + Trastuzumab + Pertuzumab166
Values in nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Tucatinib + Trastuzumab + Pertuzumab137.0192.19Not reportedNot reportedNot reported
Cycle 5

Analysis denominator · Participants

GroupSource count
Tucatinib + Trastuzumab + Pertuzumab177
Values in nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Tucatinib + Trastuzumab + Pertuzumab155.4180.92Not reportedNot reportedNot reported
Cycle 6

Analysis denominator · Participants

GroupSource count
Tucatinib + Trastuzumab + Pertuzumab183
Values in nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Tucatinib + Trastuzumab + Pertuzumab146.03215.17Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        180.04
        value
        151.83
    denoms
    1. counts
      1. group Id
        OG000
        value
        166
      units
      Participants
    title
    Cycle 2
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        144.77
        value
        158.63
    denoms
    1. counts
      1. group Id
        OG000
        value
        159
      units
      Participants
    title
    Cycle 3
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        192.19
        value
        137.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        166
      units
      Participants
    title
    Cycle 4
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        180.92
        value
        155.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        177
      units
      Participants
    title
    Cycle 5
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        215.17
        value
        146.03
    denoms
    1. counts
      1. group Id
        OG000
        value
        183
      units
      Participants
    title
    Cycle 6
denoms
  1. counts
    1. group Id
      OG000
      value
      321
    units
    Participants
description
Concentration at Trough was defined as predose/trough concentration observed directly from data.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants with locally advanced HER2+/ mBC were allocated to receive tucatinib 300 mg PO BID with trastuzumab 6 mg/kg IV or at a fixed dose of 600 mg SC, and pertuzumab 420 mg IV once every 21 days. Participants may also have received a fixed dose combination of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase SC, once every 21 days. Participants received study treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.
    id
    OG000
    title
    Tucatinib + Trastuzumab + Pertuzumab
param Type
GEOMETRIC_MEAN
population Description
PK analysis set included all randomized participants who received at least one dose of tucatinib and had at least one evaluable PK assessment. Results were not reported for placebo+Trastuzumab+Pertuzumab arm as more than 50% of concentrations were below the lower limit of quantification(as expected) as prespecified in statistical analysis plan. Overall number of participants analyzed=participants evaluable for this outcome measure. Number Analyzed=participants evaluable for specified rows.
reporting Status
POSTED
time Frame
Pre-dose on Day 1 of Cycles 2, 3, 4, 5 and 6
title
Trough Concentration (Ctrough) of Tucatinib
type
SECONDARY
unit Of Measure
nanograms per milliliter

Download exact source JSON → · Snapshot ctgov-results-aad7e863b8b06225cd4e94e7

Preserved source evidence · Not medical advice