Phase 3
N=347
A Study to Evaluate Patient Preference for Home Administration of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration in Participants With Early or Locally Advanced/Inflammatory HER2-Positive Breast Cancer
Early Breast Cancer · Locally Advanced Breast Cancer · Inflammatory Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT05415215 ↗Enrolled (actual)
347
Serious AEs
6.2%
Results posted
Jan 2026
Primary outcome: Primary: Cross-over Period: Percentage of Participants Who Preferred the Administration of PH FDC SC in the Home Setting Compared With the Hospital Setting in Question 1 of the Patient Preference Questionnaire (PPQ) — 69.0; 59.0; 23.0; 39.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fixed Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Use (PH FDC SC) (Drug); Pertuzumab IV (Drug); Trastuzumab IV (Drug); Trastuzumab Emtansine (Drug); Investigator's Choice of Chemotherapy (Drug); Surgery (Procedure); Radiotherapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cross-over Period: Percentage of Participants Who Preferred the Administration of PH FDC SC in the Home Setting Compared With the Hospital Setting in Question 1 of the Patient Preference Questionnaire (PPQ) |
69.0; 59.0; 23.0; 39.8; 8.0; 1.2 | — |
| SECONDARY Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area |
0; 100; 100; 0; 0; 100 | — |
| SECONDARY Neoadjuvant Phase: Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1b of HCPQ - Drug Preparation Area |
20.0; 5.0; 20.5; 5.0; 20.0; 5.0 | — |
| SECONDARY Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area |
1.1; 2.4; 3.4; 2.4; 13.5; 11.0 | — |
| SECONDARY Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment |
0; 100; 100; 0; 24.2; 0 | — |
| SECONDARY Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment |
5.0; 5.0; 180.0; 8.0; 420.0; 180.0 | — |
| SECONDARY Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment |
1.0; 3.0; 8.2; 13.4; 14.4; 13.4 | — |
| SECONDARY Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment |
0; 2.4; 8.2; 4.2; 20.4; 34.3 | — |
| SECONDARY Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment |
8.0; 1.2; 68.2; 83.9; 13.6; 8.7 | — |
| SECONDARY Percentage of Participants Who Achieved pCR Post-surgery |
60.2; 60.9 | — |
| SECONDARY Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores |
79.86; 75.97; -9.43; -7.40; -10.42; -11.75 | — |
| SECONDARY Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores |
76.98; 71.79; 0.66; 0.09; 2.08; 5.15 | — |
| SECONDARY Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area |
0; 90.6; 72.6; 9.4; 17.7; 0 | — |
| SECONDARY Adjuvant Cross-over Period: Duration of Treatment Preparation, According to HCPs' Responses to Question 1b of the HCPQ - Drug Preparation Area |
5.0; 5.0; 5.0; 1.0; 5.0; 4.0 | — |
| SECONDARY Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area |
2.5; 1.3; 0; 18.7; 6.2; 16.0 | — |
| SECONDARY Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment |
82.5; 60.0; 60.0; 60.0; 5.0; 5.0 | — |
| SECONDARY Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment |
35.6; 14.5; 64.4; 85.5; 7.1; 4.3 | — |
| SECONDARY Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment |
10.7; 27.0; 28.6; 16.2; 14.3; 16.2 | — |
| SECONDARY Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment |
6.3; 0; 0; 1.3; 6.3; 8.0 | — |
| SECONDARY Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment |
84.0; 45.9; 7.4; 40.5; 6.2; 6.8 | — |
| SECONDARY Adjuvant Phase: HRQoL Assessed by EORTC QLQ C30 Scores in Participants Treated With Trastuzumab Emtansine IV |
— | — |
| 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 |
68.8; 54.3; 31.2; 45.7 | — |
| SECONDARY Neoadjuvant Phase: Number of Participants With Adverse Events (AEs), Grade ≥ 3 AEs, Serious AEs (SAEs), and Cardiac AEs |
113; 227; 19; 43; 46; 103 | — |
| SECONDARY Neoadjuvant Phase: Number of Participants With Premature Withdrawal From PH FDC SC and P+H IV Due to AEs |
1; 8 | — |
| SECONDARY Adjuvant Cross-over Period: Number of Participants With AEs, Grade ≥ 3 AEs, SAEs, and Cardiac AEs |
99; 89; 1; 1; 1; 2 | — |
| SECONDARY Adjuvant Cross-over Period: Number of Participants With Premature Withdrawal From PH FDC SC Due to AEs |
2; 2 | — |
| SECONDARY Treatment Continuation Period and Trastuzumab Emtansine IV Period: Number of Participants With AEs, Grade ≥ 3 AEs, SAEs, and Cardiac AEs |
— | — |
| SECONDARY Treatment Continuation Period and Trastuzumab Emtansine IV Period: Number of Participants With Premature Withdrawal From PH FDC SC and Trastuzumab Emtansine IV Due to AEs |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Intact skin at planned site of subcutaneous (SC) injections
- Left ventricular ejection fraction (LVEF) greater than or equal to (≥)55% by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
- Negative human immunodeficiency virus (HIV) test at screening
- Negative hepatitis B surface antigen (HBsAg) test at screening
- Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening accompanied by either of the following: Negative total hepatitis B core antibody (HBcAb); Positive total HBcAb test followed by a negative (per local laboratory definition) hepatitis B virus (HBV) DNA test
- Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
- For female participants of childbearing potential: agreement to remain abstinent or use contraception and agree to refrain from donating eggs during the treatment period and for 7 months after the final dose of the study treatment
- For male participants: agreement to remain abstinent or use a condom, and agree to refrain from donating sperm during the treatment period and for 7 months after the final dose of study treatment
Disease-specific Inclusion Criteria:
- Female and male participants with stage II-IIIC early or locally advanced/inflammatory human epidermal growth factor receptor 2-positive (HER2+) breast cancer
- Primary tumor >2 centimetres (cm) in diameter, or node-positive disease
- HER2+ breast cancer confirmed by a local laboratory prior to study enrollment. HER2+ status will be determined based on pretreatment breast biopsy material and defined as 3+ by Immunohistochemistry (IHC) and/or positive by HER2 amplification by in situ hybridization (ISH) following American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines 2018 and updates (Wolff et al. Arch Pathol Lab Med 2018)
- Hormone receptor status of the primary tumor determined by local assessment following American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines and updates (Allison et al. J Clin Oncol 2020)
- Agreement to undergo mastectomy or breast conserving surgery after neoadjuvant therapy, including the axillary nodes
- Availability of formalin-fixed, paraffin-embedded (FFPE) tumor tissue block for local confirmation of HER2 and hormone receptor status following current ASCO/CAP guidelines
Inclusion Criteria for Treatment with Adjuvant PH FDC SC:
- Completed the neoadjuvant phase of this study and underwent surgery, and achieved pathologic complete response (pCR), defined as eradication of invasive disease in the breast and axilla according to the current American Joint Committee on Cancer (AJCC) staging system classification, and using the resected specimen by the local pathologist on the basis of guidelines to be provided in a pathology manual
- Adequate wound healing after breast cancer surgery per investigator's assessment to allow initiation of study treatment within less than or equal to (≤)9 weeks of last systemic neoadjuvant therapy
Exclusion Criteria
- Stage IV (metastatic) breast cancer
- History of concurrent or previously treated non-breast malignancies, except for appropriately treated 1) non-melanoma skin cancer and/or 2) in situ carcinomas, including cervix, colon, and skin. A participant with previous invasive non-breast cancer is eligible provided he/she has been disease free for more than 5 years
- Participants who are pregnant or breastfeeding or intending to become pregnant during the study or within 7 months after the final dose of study treatments
- Treatment with investigational therapy within 28 days prior to initiation of study treatment
- Active, unresolved infections at screening requiring treatment
- Participants who may have had a recent episode of thromboembolism and are still trying to optimi
Data sourced from ClinicalTrials.gov (NCT05415215). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.