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NCT02400476 · OUTCOME

Percentage of Patients With Grade 3 or Higher Diarrhea, According to NCI CTCAE v4.0.

An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide · Source last updated 2022-05-06

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
From first dose of investigational product through 28 days after last dose, up to 15.5 months.

What was measured

The primary objective of this study is to characterize the percentage of patients with Grade 3 or higher diarrhea in patients with early-stage HER2 overexpressed/amplified (HER2+) breast cancer treated with neratinib when administered with intensive loperamide prophylaxis, after prior treatment with trastuzumab. Grade 3: Increase of \>=7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self care ADL. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death.

Groups in this outcome

Loperamide

240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Loperamide daily for two 28-day cycles and then as needed. Neratinib Loperamide

Budesonide and Loperamide

240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Anti-inflammatory treatment for 1 cycle and Loperamide to be administered daily for two 28-day cycles and then as needed, thereafter. Neratinib Loperamide Budesonide: 9 mg extended release tablets once daily with or without food for 28 days

Colestipol and Loperamide

240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Colestipol for 1 cycle and loperamide to be administered 1 cycle and then as needed, thereafter. Neratinib Loperamide Colestipol: 2 g twice daily with or without food for one 28 day cycle

Colestipol With Loperamide as Needed

240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Colestipol for 1 cycle and loperamide to be administered as needed. Neratinib Loperamide Colestipol: 2 g twice daily with or without food for one 28 day cycle

Neratinib Dose Escalation 1

120 mg Neratinib for Week 1, followed by 160 mg Neratinib starting for Week 2, followed by 240 mg Neratinib starting at Week 3 and thereafter (C1D15 to End of Treatment). Loperamide administered as needed. Neratinib Loperamide

Neratinib Dose Escalation 2

160 mg neratinib for the first 2 weeks, followed by 200 mg neratinib for the next 2 weeks, followed by 240 mg neratinib thereafter (C2D1 to End of treatment. Loperamide will be administered on an as-needed basis only. Neratinib Loperamide

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

Analysis denominator · Participants

GroupSource count
Loperamide137
Budesonide and Loperamide64
Colestipol and Loperamide136
Colestipol With Loperamide as Needed104
Neratinib Dose Escalation 160
Neratinib Dose Escalation 262

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Loperamide30.7Not reported23.139.1Not reported
Budesonide and Loperamide28.1Not reported17.640.8Not reported
Colestipol and Loperamide20.6Not reported14.128.4Not reported
Colestipol With Loperamide as Needed32.7Not reported23.842.6Not reported
Neratinib Dose Escalation 113.3Not reported5.924.6Not reported
Neratinib Dose Escalation 227.4Not reported16.940.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        23.1
        upper Limit
        39.1
        value
        30.7
      2. group Id
        OG001
        lower Limit
        17.6
        upper Limit
        40.8
        value
        28.1
      3. group Id
        OG002
        lower Limit
        14.1
        upper Limit
        28.4
        value
        20.6
      4. group Id
        OG003
        lower Limit
        23.8
        upper Limit
        42.6
        value
        32.7
      5. group Id
        OG004
        lower Limit
        5.9
        upper Limit
        24.6
        value
        13.3
      6. group Id
        OG005
        lower Limit
        16.9
        upper Limit
        40.2
        value
        27.4
denoms
  1. counts
    1. group Id
      OG000
      value
      137
    2. group Id
      OG001
      value
      64
    3. group Id
      OG002
      value
      136
    4. group Id
      OG003
      value
      104
    5. group Id
      OG004
      value
      60
    6. group Id
      OG005
      value
      62
    units
    Participants
description
The primary objective of this study is to characterize the percentage of patients with Grade 3 or higher diarrhea in patients with early-stage HER2 overexpressed/amplified (HER2+) breast cancer treated with neratinib when administered with intensive loperamide prophylaxis, after prior treatment with trastuzumab. Grade 3: Increase of \>=7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self care ADL. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death.
dispersion Type
95% Confidence Interval
groups
  1. description
    240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Loperamide daily for two 28-day cycles and then as needed. Neratinib Loperamide
    id
    OG000
    title
    Loperamide
  2. description
    240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Anti-inflammatory treatment for 1 cycle and Loperamide to be administered daily for two 28-day cycles and then as needed, thereafter. Neratinib Loperamide Budesonide: 9 mg extended release tablets once daily with or without food for 28 days
    id
    OG001
    title
    Budesonide and Loperamide
  3. description
    240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Colestipol for 1 cycle and loperamide to be administered 1 cycle and then as needed, thereafter. Neratinib Loperamide Colestipol: 2 g twice daily with or without food for one 28 day cycle
    id
    OG002
    title
    Colestipol and Loperamide
  4. description
    240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Colestipol for 1 cycle and loperamide to be administered as needed. Neratinib Loperamide Colestipol: 2 g twice daily with or without food for one 28 day cycle
    id
    OG003
    title
    Colestipol With Loperamide as Needed
  5. description
    120 mg Neratinib for Week 1, followed by 160 mg Neratinib starting for Week 2, followed by 240 mg Neratinib starting at Week 3 and thereafter (C1D15 to End of Treatment). Loperamide administered as needed. Neratinib Loperamide
    id
    OG004
    title
    Neratinib Dose Escalation 1
  6. description
    160 mg neratinib for the first 2 weeks, followed by 200 mg neratinib for the next 2 weeks, followed by 240 mg neratinib thereafter (C2D1 to End of treatment. Loperamide will be administered on an as-needed basis only. Neratinib Loperamide
    id
    OG005
    title
    Neratinib Dose Escalation 2
param Type
NUMBER
reporting Status
POSTED
time Frame
From first dose of investigational product through 28 days after last dose, up to 15.5 months.
title
Percentage of Patients With Grade 3 or Higher Diarrhea, According to NCI CTCAE v4.0.
type
PRIMARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice