Arm C: Adjuvant PH FDC SC in Hospital, Then at Home for Inflammatory Breast Cancer (IBC)
Phase-Based Progress Estimates
Effectiveness
Safety
Hospital Clinico Universitario de Salamanca; Servicio de Oncologia, Salamanca, Spain
Inflammatory Breast Cancer (IBC)+4 More
Fixed Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Use (PH FDC SC) - DrugEligibility
18+
All Sexes
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Eligibility
18+
All Sexes
What conditions do you have?
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Study 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.
Eligible Conditions
- Inflammatory Breast Cancer (IBC)
- Early Breast Cancer
- Locally Advanced Breast Cancer (LABC)
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 27 Secondary · Reporting Duration: From first dose post-surgery until the last dose of adjuvant treatment (up to 1.5 years)
Week 3
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
Week 3
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
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
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
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
Percentage of Healthcare Professionals by Their Responses to Question 7 of the HCPQ - Adjuvant Phase Administering Treatment
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
Week 3
Health-Related Quality of Life Assessed by the EORTC QLQ-C30 Questionnaire Scores in Participants Treated with PH FDC SC During the Adjuvant Phase
Week 3
Health-Related Quality of Life Assessed by the EORTC QLQ-C30 Questionnaire Scores in Participants Treated with Trastuzumab Emtansine During the Adjuvant Phase
Week 3
Duration of Treatment Administration Activities, According to Healthcare Professionals' Responses to Question 1 of the HCPQ - Adjuvant Phase Administering Treatment
Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1 of the HCPQ - Adjuvant Phase Drug Preparation Area
Week 3
Duration of Treatment Administration Activities, According to Healthcare Professionals' Responses to Question 1 of the HCPQ - Neoadjuvant Phase Administering Treatment
Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1 of the Healthcare Professional Questionnaire (HCPQ) - Neoadjuvant Phase Drug Preparation Area
Week 3
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
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
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
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
Percentage of Healthcare Professionals by Their Responses to Question 11 of the HCPQ - Neoadjuvant Phase Administering Treatment
Week 27
Number of Participants with Clinical Laboratory Test Abnormalities During the Neoadjuvant Treatment Phase
Number of Participants with Vital Sign Abnormalities During the Neoadjuvant Treatment Phase
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)
Week 3
Incidence of Premature Withdrawal from Adjuvant Treatment with Trastuzumab Emtansine
Week 3
Incidence of Premature Withdrawal from Adjuvant Treatment with PH FDC SC
Week 3
Incidence of Premature Withdrawal from Neoadjuvant Treatment with PH FDC SC or Pertuzumab IV and Trastuzumab IV
Year 5
Number of Participants with Clinical Laboratory Test Abnormalities During the Adjuvant Treatment Phase
Number of Participants with Vital Sign Abnormalities During the Adjuvant Treatment Phase
Year 2
Number of Participants with at Least One Adverse Event During the Adjuvant Treatment Phase, with Severity Determined According to the NCI CTCAE v5.0
Week 27
Percentage of Participants Achieving Pathologic Complete Response (pCR)
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
Arm C: Adjuvant PH FDC SC in Hospital, Then at Home
1 of 2
Arm D: Adjuvant PH FDC SC at Home, Then in Hospital
1 of 2
Experimental Treatment
330 Total Participants · 2 Treatment Groups
Primary Treatment: Arm C: Adjuvant PH FDC SC in Hospital, Then at Home · No Placebo Group · Phase 3
Arm C: Adjuvant PH FDC SC in Hospital, Then at Home
Drug
Experimental Group · 1 Intervention: Fixed Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Use (PH FDC SC) · Intervention Types: DrugArm D: Adjuvant PH FDC SC at Home, Then in Hospital
Drug
Experimental Group · 1 Intervention: Fixed Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Use (PH FDC SC) · Intervention Types: DrugTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from first dose post-surgery until the last dose of adjuvant treatment (up to 1.5 years)
Closest Location: Hopital du Saint Sacrement · Quebec City, Canada
2021First Recorded Clinical Trial
1 TrialsResearching Inflammatory Breast Cancer (IBC)
4 CompletedClinical Trials
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have a negative HIV test result.
You have a performance status of 0 or 1.
The skin at the planned site of the subcutaneous (SC) injection is intact.
You have been tested for hepatitis C virus (HCV) antibodies and have been negative.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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