Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01401166 · OUTCOME

Percentage of HCPs by Most Satisfied 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 HCPs
Interval / dispersion
Not reported
Time frame
Week 24

What was measured

The method of drug administration with which HCPs were most satisfied (IV or SC Herceptin) was assessed via questionnaire with each HCP using the question, "All things considered, with which method of administration were you most satisfied?" at the end of the crossover period (Week 24). The percentage of HCPs who were most satisfied with each method of drug administration was reported.

Analysis population: HCP Population: All HCPs who participated in the study and completed the HCP questionnaire. Results were planned to be analyzed for all HCPs combined because the objective of the study was to compare preference between SC and IV Herceptin.

Groups in this outcome

All HCPs: SC and IV Herceptin

Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via SID (Cohort 1) or vial (Cohort 2) for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received IV Herceptin (Cohort 1) or SC Herceptin (Cohort 2) for up to 10 remaining cycles. Participants in Cohort 1 with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered to self-administer SC Herceptin via SID under the direction of a trained HCP, whereas in Cohort 2, administration was performed by HCP throughout the study. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for both SID and vial.

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

Analysis denominator · Participants

GroupSource count
All HCPs: SC and IV Herceptin235

Analysis denominator · HCPs

GroupSource count
All HCPs: SC and IV Herceptin235

Reported measurements

SC Herceptin
Values in percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All HCPs: SC and IV Herceptin77.0Not reportedNot reportedNot reportedNot reported
IV Herceptin
Values in percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All HCPs: SC and IV Herceptin3.0Not reportedNot reportedNot reportedNot reported
No Preference
Values in percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All HCPs: SC and IV Herceptin20.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        77.0
    title
    SC Herceptin
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3.0
    title
    IV Herceptin
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        20.0
    title
    No Preference
denom Units Selected
HCPs
denoms
  1. counts
    1. group Id
      OG000
      value
      235
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      235
    units
    HCPs
description
The method of drug administration with which HCPs were most satisfied (IV or SC Herceptin) was assessed via questionnaire with each HCP using the question, "All things considered, with which method of administration were you most satisfied?" at the end of the crossover period (Week 24). The percentage of HCPs who were most satisfied with each method of drug administration was reported.
groups
  1. description
    Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via SID (Cohort 1) or vial (Cohort 2) for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received IV Herceptin (Cohort 1) or SC Herceptin (Cohort 2) for up to 10 remaining cycles. Participants in Cohort 1 with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered to self-administer SC Herceptin via SID under the direction of a trained HCP, whereas in Cohort 2, administration was performed by HCP throughout the study. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for both SID and vial.
    id
    OG000
    title
    All HCPs: SC and IV Herceptin
param Type
NUMBER
population Description
HCP Population: All HCPs who participated in the study and completed the HCP questionnaire. Results were planned to be analyzed for all HCPs combined because the objective of the study was to compare preference between SC and IV Herceptin.
reporting Status
POSTED
time Frame
Week 24
title
Percentage of HCPs by Most Satisfied Method of Drug Administration
type
SECONDARY
type Units Analyzed
HCPs
unit Of Measure
percentage of HCPs

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

Preserved source evidence · Not medical advice