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NCT03674112 · OUTCOME

Percentage of Healthcare Professionals (HCPs) by Their Responses on Perception of Time/Resource Use of Each Study Regimen, Questions 3 and 4 of the HCPQ - Drug Preparation 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 prepared study treatment within the pharmacy/drug preparation area responded at Cycle 6 of the Treatment Cross-Over Period to the following HCPQ-Drug Preparation Room Questions 3 and 4: "Looking back over the Perjeta-Herceptin treatment sessions, please indicate based on your opinion which administration method: Q3. Was quickest from start to end of preparation to finish of administration (excluding observation period)?; Q4. Required less resource use for preparation and administration, for example nursing time, facility costs, equipment etc?" The three available response options were: P+H IV, FDC SC, and No Difference.

Analysis population: The number analyzed includes healthcare professionals (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 Professionals160
A: P+H IV Followed by PH FDC SC80
B: PH FDC SC Followed by P+H IV80

Reported measurements

Q3. Answer: FDC SC
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals87.5Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC92.5Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV82.5Not reportedNot reportedNot reportedNot reported
Q3. Answer: P+H IV
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 SC0.0Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV1.3Not reportedNot reportedNot reportedNot reported
Q3. Answer: No Difference
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals1.3Not 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 IV1.3Not reportedNot reportedNot reportedNot reported
Q3. Answer: Missing
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals10.6Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC6.3Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV15.0Not reportedNot reportedNot reportedNot reported
Q4. Answer: FDC SC
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals86.9Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC93.8Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV80.0Not reportedNot reportedNot reportedNot reported
Q4. Answer: P+H IV
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals0.0Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC0.0Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV0.0Not reportedNot reportedNot reportedNot reported
Q4. Answer: No Difference
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals2.5Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC0.0Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV5.0Not reportedNot reportedNot reportedNot reported
Q4. Answer: Missing
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals10.6Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC6.3Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV15.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        87.5
      2. group Id
        OG001
        value
        92.5
      3. group Id
        OG002
        value
        82.5
    title
    Q3. Answer: FDC SC
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0.6
      2. group Id
        OG001
        value
        0.0
      3. group Id
        OG002
        value
        1.3
    title
    Q3. Answer: P+H IV
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1.3
      2. group Id
        OG001
        value
        1.3
      3. group Id
        OG002
        value
        1.3
    title
    Q3. Answer: No Difference
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        10.6
      2. group Id
        OG001
        value
        6.3
      3. group Id
        OG002
        value
        15.0
    title
    Q3. Answer: Missing
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        86.9
      2. group Id
        OG001
        value
        93.8
      3. group Id
        OG002
        value
        80.0
    title
    Q4. Answer: FDC SC
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0
      2. group Id
        OG001
        value
        0.0
      3. group Id
        OG002
        value
        0.0
    title
    Q4. Answer: P+H IV
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        2.5
      2. group Id
        OG001
        value
        0.0
      3. group Id
        OG002
        value
        5.0
    title
    Q4. Answer: No Difference
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        10.6
      2. group Id
        OG001
        value
        6.3
      3. group Id
        OG002
        value
        15.0
    title
    Q4. Answer: Missing
denoms
  1. counts
    1. group Id
      OG000
      value
      160
    2. group Id
      OG001
      value
      80
    3. group Id
      OG002
      value
      80
    units
    Participants
description
Healthcare professionals (HCPs) who prepared study treatment within the pharmacy/drug preparation area responded at Cycle 6 of the Treatment Cross-Over Period to the following HCPQ-Drug Preparation Room Questions 3 and 4: "Looking back over the Perjeta-Herceptin treatment sessions, please indicate based on your opinion which administration method: Q3. Was quickest from start to end of preparation to finish of administration (excluding observation period)?; Q4. Required less resource use for preparation and administration, for example nursing time, facility costs, equipment etc?" The three available response options were: P+H IV, FDC SC, and No Difference.
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 healthcare professionals (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 on Perception of Time/Resource Use of Each Study Regimen, Questions 3 and 4 of the HCPQ - Drug Preparation Room
type
SECONDARY
unit Of Measure
Percentage of HCPs

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Preserved source evidence · Not medical advice