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NCT03674112 · OUTCOME

Percentage of Healthcare Professionals (HCPs) by Their Responses to Question 8 of the HCPQ - Treatment Room

A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer · Source last updated 2024-01-02

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
Day 1 of Cycle 6 (each cycle is 21 days)

What was measured

Healthcare professionals (HCPs) who administered study treatment responded at Cycle 6 of the Treatment Cross-Over Period to the following HCPQ-Treatment Room Question 8: "How frequently would you offer or recommend FDC SC administration to your patients in the future?" The three available response options were: Always, Sometimes, and Never.

Analysis population: The number analyzed includes HCPs who completed any part of the survey at treatment Cycle 6.

Groups in this outcome

All Healthcare Professionals

This analysis set includes all healthcare professionals who treated participants from Arms A and B and completed the HCPQ questionnaire, which was administered at the last treatment cycle in the Treatment Cross-Over Period of the study. During the Treatment Cross-Over Period of the study, all participants received their first 6 cycles of treatment in accordance with the study arm to which they were randomized: Arm A) pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles followed by the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days); or Arm B) PH FDC SC for 3 treatment cycles followed by P+H IV for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.

A: P+H IV Followed by PH FDC SC

In the Treatment Cross-Over Period of the study, participants randomized to Arm A first received pertuzumab IV and trastuzumab IV (P+H IV) administration for 3 treatment cycles followed by the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.

B: PH FDC SC Followed by P+H IV

In the Treatment Cross-Over Period of the study, participants randomized to Arm B first received the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles followed by pertuzumab intravenous (IV) and trastuzumab IV (P+H IV) administration for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.

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 Healthcare Professionals159
A: P+H IV Followed by PH FDC SC79
B: PH FDC SC Followed by P+H IV80

Reported measurements

Always
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals67.3Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC69.6Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV65.0Not reportedNot reportedNot reportedNot reported
Sometimes
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals30.2Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC26.6Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV33.8Not reportedNot reportedNot reportedNot reported
Never
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals0.6Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC1.3Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV0.0Not reportedNot reportedNot reportedNot reported
Missing
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals1.9Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC2.5Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV1.3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        67.3
      2. group Id
        OG001
        value
        69.6
      3. group Id
        OG002
        value
        65.0
    title
    Always
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        30.2
      2. group Id
        OG001
        value
        26.6
      3. group Id
        OG002
        value
        33.8
    title
    Sometimes
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0.6
      2. group Id
        OG001
        value
        1.3
      3. group Id
        OG002
        value
        0.0
    title
    Never
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1.9
      2. group Id
        OG001
        value
        2.5
      3. group Id
        OG002
        value
        1.3
    title
    Missing
denoms
  1. counts
    1. group Id
      OG000
      value
      159
    2. group Id
      OG001
      value
      79
    3. group Id
      OG002
      value
      80
    units
    Participants
description
Healthcare professionals (HCPs) who administered study treatment responded at Cycle 6 of the Treatment Cross-Over Period to the following HCPQ-Treatment Room Question 8: "How frequently would you offer or recommend FDC SC administration to your patients in the future?" The three available response options were: Always, Sometimes, and Never.
groups
  1. description
    This analysis set includes all healthcare professionals who treated participants from Arms A and B and completed the HCPQ questionnaire, which was administered at the last treatment cycle in the Treatment Cross-Over Period of the study. During the Treatment Cross-Over Period of the study, all participants received their first 6 cycles of treatment in accordance with the study arm to which they were randomized: Arm A) pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles followed by the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days); or Arm B) PH FDC SC for 3 treatment cycles followed by P+H IV for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
    id
    OG000
    title
    All Healthcare Professionals
  2. description
    In the Treatment Cross-Over Period of the study, participants randomized to Arm A first received pertuzumab IV and trastuzumab IV (P+H IV) administration for 3 treatment cycles followed by the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
    id
    OG001
    title
    A: P+H IV Followed by PH FDC SC
  3. description
    In the Treatment Cross-Over Period of the study, participants randomized to Arm B first received the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles followed by pertuzumab intravenous (IV) and trastuzumab IV (P+H IV) administration for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
    id
    OG002
    title
    B: PH FDC SC Followed by P+H IV
param Type
NUMBER
population Description
The number analyzed includes HCPs who completed any part of the survey at treatment Cycle 6.
reporting Status
POSTED
time Frame
Day 1 of Cycle 6 (each cycle is 21 days)
title
Percentage of Healthcare Professionals (HCPs) by Their Responses to Question 8 of the HCPQ - Treatment Room
type
SECONDARY
unit Of Measure
Percentage of HCPs

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Preserved source evidence · Not medical advice