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NCT01401166 · OUTCOME

Percentage of Participants by Preferred Method of Drug Administration

Participant Preference of Subcutaneous (SC) Versus Intravenous (IV) Herceptin (Trastuzumab) in Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer · Source last updated 2017-03-06

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
Not reported
Time frame
Week 24

What was measured

The preferred method of drug administration (IV or SC Herceptin) was assessed in trial-specific telephone interviews with each study participant. Participants were asked, "All things considered, which method of administration did you prefer?" at the end of the crossover period (Week 24). The percentage of participants who preferred each method of drug administration was reported.

Analysis population: Intent-to-Treat (ITT) Population: All participants who received both IV and SC Herceptin and who completed the trial-specific telephone interview conducted after the end of the crossover period.

Groups in this outcome

Cohort 1: SC (SID) Then IV Herceptin

Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.

Cohort 1: IV Then SC (SID) Herceptin

Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.

Cohort 2: SC (Vial) Then IV Herceptin

Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.

Cohort 2: IV Then SC (Vial) Herceptin

Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via handheld syringe using the vial formulation. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.

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

Analysis denominator · Participants

GroupSource count
Cohort 1: SC (SID) Then IV Herceptin117
Cohort 1: IV Then SC (SID) Herceptin119
Cohort 2: SC (Vial) Then IV Herceptin118
Cohort 2: IV Then SC (Vial) Herceptin113

Reported measurements

SC Herceptin
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: SC (SID) Then IV Herceptin95.7Not reportedNot reportedNot reportedNot reported
Cohort 1: IV Then SC (SID) Herceptin87.4Not reportedNot reportedNot reportedNot reported
Cohort 2: SC (Vial) Then IV Herceptin83.9Not reportedNot reportedNot reportedNot reported
Cohort 2: IV Then SC (Vial) Herceptin88.5Not reportedNot reportedNot reportedNot reported
IV Herceptin
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: SC (SID) Then IV Herceptin4.3Not reportedNot reportedNot reportedNot reported
Cohort 1: IV Then SC (SID) Herceptin9.2Not reportedNot reportedNot reportedNot reported
Cohort 2: SC (Vial) Then IV Herceptin13.6Not reportedNot reportedNot reportedNot reported
Cohort 2: IV Then SC (Vial) Herceptin11.5Not reportedNot reportedNot reportedNot reported
No Preference
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: SC (SID) Then IV Herceptin0.0Not reportedNot reportedNot reportedNot reported
Cohort 1: IV Then SC (SID) Herceptin3.4Not reportedNot reportedNot reportedNot reported
Cohort 2: SC (Vial) Then IV Herceptin2.5Not reportedNot reportedNot reportedNot reported
Cohort 2: IV Then SC (Vial) Herceptin0.0Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.903
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.986
    estimate Comment
    The estimated proportion of participants who preferred SC Herceptin and the corresponding exact binomial confidence interval (CI) were determined.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Estimated Proportion
    param Value
    0.957
  2. ci Lower Limit
    0.908
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.986
    estimate Comment
    The estimated proportion of participants who preferred SC Herceptin and the corresponding CI were determined using logistic regression with factors of previous Herceptin status and treatment.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Estimated Proportion
    param Value
    0.964
  3. ci Lower Limit
    0.801
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.928
    estimate Comment
    The estimated proportion of participants who preferred SC Herceptin and the corresponding exact binomial CI were determined.
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Estimated Proportion
    param Value
    0.874
  4. ci Lower Limit
    0.804
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.943
    estimate Comment
    The estimated proportion of participants who preferred SC Herceptin and the corresponding CI were determined using logistic regression with factors of previous Herceptin status and treatment.
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Estimated Proportion
    param Value
    0.892
  5. ci Lower Limit
    0.760
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.900
    estimate Comment
    The estimated proportion of participants who preferred SC Herceptin and the corresponding exact binomial CI were determined.
    group Ids
    1. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Estimated Proportion
    param Value
    0.839
  6. ci Lower Limit
    0.776
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.933
    estimate Comment
    The estimated proportion of participants who preferred SC Herceptin and the corresponding CI were determined using logistic regression with factors of previous Herceptin status and treatment.
    group Ids
    1. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Estimated Proportion
    param Value
    0.874
  7. ci Lower Limit
    0.811
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.937
    estimate Comment
    The estimated proportion of participants who preferred SC Herceptin and the corresponding exact binomial CI were determined.
    group Ids
    1. OG003
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Estimated Proportion
    param Value
    0.885
  8. ci Lower Limit
    0.827
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.956
    estimate Comment
    The estimated proportion of participants who preferred SC Herceptin and the corresponding CI were determined using logistic regression with factors of previous Herceptin status and treatment.
    group Ids
    1. OG003
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Estimated Proportion
    param Value
    0.911
Complete source fields
analyses
  1. ci Lower Limit
    0.903
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.986
    estimate Comment
    The estimated proportion of participants who preferred SC Herceptin and the corresponding exact binomial confidence interval (CI) were determined.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Estimated Proportion
    param Value
    0.957
  2. ci Lower Limit
    0.908
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.986
    estimate Comment
    The estimated proportion of participants who preferred SC Herceptin and the corresponding CI were determined using logistic regression with factors of previous Herceptin status and treatment.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Estimated Proportion
    param Value
    0.964
  3. ci Lower Limit
    0.801
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.928
    estimate Comment
    The estimated proportion of participants who preferred SC Herceptin and the corresponding exact binomial CI were determined.
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Estimated Proportion
    param Value
    0.874
  4. ci Lower Limit
    0.804
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.943
    estimate Comment
    The estimated proportion of participants who preferred SC Herceptin and the corresponding CI were determined using logistic regression with factors of previous Herceptin status and treatment.
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Estimated Proportion
    param Value
    0.892
  5. ci Lower Limit
    0.760
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.900
    estimate Comment
    The estimated proportion of participants who preferred SC Herceptin and the corresponding exact binomial CI were determined.
    group Ids
    1. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Estimated Proportion
    param Value
    0.839
  6. ci Lower Limit
    0.776
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.933
    estimate Comment
    The estimated proportion of participants who preferred SC Herceptin and the corresponding CI were determined using logistic regression with factors of previous Herceptin status and treatment.
    group Ids
    1. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Estimated Proportion
    param Value
    0.874
  7. ci Lower Limit
    0.811
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.937
    estimate Comment
    The estimated proportion of participants who preferred SC Herceptin and the corresponding exact binomial CI were determined.
    group Ids
    1. OG003
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Estimated Proportion
    param Value
    0.885
  8. ci Lower Limit
    0.827
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.956
    estimate Comment
    The estimated proportion of participants who preferred SC Herceptin and the corresponding CI were determined using logistic regression with factors of previous Herceptin status and treatment.
    group Ids
    1. OG003
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Estimated Proportion
    param Value
    0.911
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        95.7
      2. group Id
        OG001
        value
        87.4
      3. group Id
        OG002
        value
        83.9
      4. group Id
        OG003
        value
        88.5
    title
    SC Herceptin
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4.3
      2. group Id
        OG001
        value
        9.2
      3. group Id
        OG002
        value
        13.6
      4. group Id
        OG003
        value
        11.5
    title
    IV Herceptin
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0
      2. group Id
        OG001
        value
        3.4
      3. group Id
        OG002
        value
        2.5
      4. group Id
        OG003
        value
        0.0
    title
    No Preference
denoms
  1. counts
    1. group Id
      OG000
      value
      117
    2. group Id
      OG001
      value
      119
    3. group Id
      OG002
      value
      118
    4. group Id
      OG003
      value
      113
    units
    Participants
description
The preferred method of drug administration (IV or SC Herceptin) was assessed in trial-specific telephone interviews with each study participant. Participants were asked, "All things considered, which method of administration did you prefer?" at the end of the crossover period (Week 24). The percentage of participants who preferred each method of drug administration was reported.
groups
  1. description
    Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
    id
    OG000
    title
    Cohort 1: SC (SID) Then IV Herceptin
  2. description
    Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
    id
    OG001
    title
    Cohort 1: IV Then SC (SID) Herceptin
  3. description
    Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
    id
    OG002
    title
    Cohort 2: SC (Vial) Then IV Herceptin
  4. description
    Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via handheld syringe using the vial formulation. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
    id
    OG003
    title
    Cohort 2: IV Then SC (Vial) Herceptin
param Type
NUMBER
population Description
Intent-to-Treat (ITT) Population: All participants who received both IV and SC Herceptin and who completed the trial-specific telephone interview conducted after the end of the crossover period.
reporting Status
POSTED
time Frame
Week 24
title
Percentage of Participants by Preferred Method of Drug Administration
type
PRIMARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice