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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05415215
Other study ID # MO43110
Secondary ID 2021-002346-3320
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date July 5, 2022
Est. completion date December 31, 2025

Study information

Verified date April 2024
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a Phase IIIb, multinational, multicenter, randomized, open-label study to evaluate patient preference of the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous use (PH FDC SC) administration in the home setting compared with the hospital setting during the cross-over period of adjuvant treatment in participants with early or locally advanced/inflammatory human epidermal growth factor receptor 2-positive (HER2+) breast cancer.


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Study Design


Intervention

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Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Argentina,  Bosnia and Herzegovina,  Brazil,  Bulgaria,  Canada,  Chile,  Costa Rica,  Croatia,  India,  Kenya,  Korea, Republic of,  Mexico,  Peru,  Singapore,  South Africa,  Spain,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants Who Preferred the Administration of PH FDC SC in the Home Setting Compared With the Hospital Setting, Question 1 of the Patient Preference Questionnaire Day 1 of Cycle 8 of adjuvant treatment (1 cycle is 3 weeks)
Secondary Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1 of the Healthcare Professional Questionnaire (HCPQ) - Neoadjuvant Phase Drug Preparation Area Day 1 of each cycle from first cycle (Cycle 1 or 5) to last cycle (Cycle 6 or 8) of PH IV or PH FDC SC neoadjuvant treatment (1 cycle is 3 weeks)
Secondary Percentage of Healthcare Professionals by Their Responses on Perception of Impact of PH FDC SC on Clinical Management and Clinical Efficiency, Question 2 of the HCPQ - Neoadjuvant Phase Drug Preparation Area Day 1 of last cycle (Cycle 6 or 8) of neoadjuvant treatment (1 cycle is 3 weeks)
Secondary Percentage of Healthcare Professionals by Their Responses on Perception of Time/Resource Use of Each Study Regimen, Questions 3 and 4 of the HCPQ - Neoadjuvant Phase Drug Preparation Area Day 1 of last cycle (Cycle 6 or 8) of neoadjuvant treatment (1 cycle is 3 weeks)
Secondary Duration of Treatment Administration Activities, According to Healthcare Professionals' Responses to Question 1 of the HCPQ - Neoadjuvant Phase Administering Treatment Day 1 of each cycle from first cycle (Cycle 1 or 5) to last cycle (Cycle 6 or 8) of PH IV or PH FDC SC neoadjuvant treatment (1 cycle is 3 weeks)
Secondary Percentage of Healthcare Professionals by Their Responses on Perception of Impact of PH FDC SC on Clinical Management and Clinical Efficiency, Question 2 of the HCPQ - Neoadjuvant Phase Administering Treatment Day 1 of last cycle (Cycle 6 or 8) of neoadjuvant treatment (1 cycle is 3 weeks)
Secondary Percentage of Healthcare Professionals by Their Responses on Perception of Time/Resource Use and Convenience of Each Study Regimen, Questions 3 to 10 of the HCPQ - Neoadjuvant Phase Administering Treatment Day 1 of last cycle (Cycle 6 or 8) of neoadjuvant treatment (1 cycle is 3 weeks)
Secondary Percentage of Healthcare Professionals by Their Responses to Question 11 of the HCPQ - Neoadjuvant Phase Administering Treatment Day 1 of last cycle (Cycle 6 or 8) of neoadjuvant treatment (1 cycle is 3 weeks)
Secondary Percentage of Participants Achieving Pathologic Complete Response (pCR) pCR is defined as eradication of invasive disease in the breast and axilla (i.e., ypT0/Tis ypN0), according to local pathologist assessment following the American Joint Committee on Cancer (AJCC) criteria. Post-surgery (up to 27 weeks)
Secondary Health-Related Quality of Life Assessed by the European Organization for Research and Treatment of Cancer Core Quality of Life (EORTC QLQ)-C30 Questionnaire Scores in the Neoadjuvant Phase Day 1 of Cycle 1 and Day 1 of last cycle of neoadjuvant treatment (Cycle 6 or 8; 1 cycle is 3 weeks)
Secondary Health-Related Quality of Life Assessed by the EORTC QLQ-C30 Questionnaire Scores in Participants Treated with PH FDC SC During the Adjuvant Phase Day 1 of Cycles 1, 3, 5, 8, and last cycle of adjuvant treatment (1 cycle is 3 weeks)
Secondary Health-Related Quality of Life Assessed by the EORTC QLQ-C30 Questionnaire Scores in Participants Treated with Trastuzumab Emtansine During the Adjuvant Phase Day 1 of Cycles 1, 7, and 14 of adjuvant treatment (1 cycle is 3 weeks)
Secondary Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1 of the HCPQ - Adjuvant Phase Drug Preparation Area Day 1 of Cycles 5 and 8 of adjuvant treatment (1 cycle is 3 weeks)
Secondary Percentage of Healthcare Professionals by Their Responses on Perception of the Treatment Setting's Impact on Clinical Management and Clinical Efficiency, Question 2 of the HCPQ - Adjuvant Phase Drug Preparation Area Day 1 of Cycle 8 of adjuvant treatment (1 cycle is 3 weeks)
Secondary Percentage of Healthcare Professionals by Their Responses on Perception of Time/Resource Use in the Home and Hospital Settings, Questions 3 and 4 of the HCPQ - Adjuvant Phase Drug Preparation Area Day 1 of Cycle 8 of adjuvant treatment (1 cycle is 3 weeks)
Secondary Duration of Treatment Administration Activities, According to Healthcare Professionals' Responses to Question 1 of the HCPQ - Adjuvant Phase Administering Treatment Day 1 of Cycles 5 and 8 of adjuvant treatment (1 cycle is 3 weeks)
Secondary Percentage of Healthcare Professionals by Their Responses on Perception of the Treatment Setting's Impact on Clinical Management and Clinical Efficiency, Question 2 of the HCPQ - Adjuvant Phase Administering Treatment Day 1 of Cycle 8 of adjuvant treatment (1 cycle is 3 weeks)
Secondary Percentage of Healthcare Professionals by Their Responses on Perception of Time/Resource Use in the Home and Hospital Settings, Questions 3 to 6 of the HCPQ - Adjuvant Phase Administering Treatment Day 1 of Cycle 8 of adjuvant treatment (1 cycle is 3 weeks)
Secondary Percentage of Healthcare Professionals by Their Responses to Question 7 of the HCPQ - Adjuvant Phase Administering Treatment Day 1 of Cycle 8 of adjuvant treatment (1 cycle is 3 weeks)
Secondary Percentage of Participants who Selected the Administration of PH FDC SC in the Home Setting Compared With the Hospital Setting in the Treatment Continuation Period Day 1 of Cycle 8 of adjuvant treatment (1 cycle is 3 weeks)
Secondary Number of Participants with at Least One Adverse Event During the Neoadjuvant Treatment Phase, with Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) From Baseline until surgery (up to 27 weeks)
Secondary Incidence of Premature Withdrawal from Neoadjuvant Treatment with PH FDC SC or Pertuzumab IV and Trastuzumab IV From Cycle 1 to last cycle (Cycle 6 or 8) of neoadjuvant treatment (1 cycle is 3 weeks)
Secondary Number of Participants with Clinical Laboratory Test Abnormalities During the Neoadjuvant Treatment Phase From Baseline until surgery (up to 27 weeks)
Secondary Number of Participants with Vital Sign Abnormalities During the Neoadjuvant Treatment Phase From Baseline until surgery (up to 27 weeks)
Secondary Number of Participants with at Least One Adverse Event During the Adjuvant Treatment Phase, with Severity Determined According to the NCI CTCAE v5.0 From first dose post-surgery up to 9 months after the last dose of adjuvant treatment (up to 2 years)
Secondary Incidence of Premature Withdrawal from Adjuvant Treatment with PH FDC SC From Cycle 1 to last cycle (Cycle 12 or 14) of adjuvant treatment (1 cycle is 3 weeks)
Secondary Incidence of Premature Withdrawal from Adjuvant Treatment with Trastuzumab Emtansine From Cycle 1 to Cycle 14 (last cycle; 1 cycle is 3 weeks)
Secondary Number of Participants with Clinical Laboratory Test Abnormalities During the Adjuvant Treatment Phase From first dose post-surgery until the last dose of adjuvant treatment (up to 1.5 years)
Secondary Number of Participants with Vital Sign Abnormalities During the Adjuvant Treatment Phase From first dose post-surgery until the last dose of adjuvant treatment (up to 1.5 years)
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