A clinical trial to look at patients preference of home dosing with a fixed-dose combination of Pertuzumab and Trastuzumab in people with early or locally advanced Her2-positive breast cancer.

A PHASE IIIB, MULTINATIONAL, MULTICENTER, RANDOMIZED, OPEN-LABEL 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 - .

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-002346-33-ES

Enrollment

330

Registered

2022-03-26

Start date

2022-05-17

Completion date

Unknown

Last updated

2022-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early or locally advanced/inflammatory HER2-positive (HER2+) breast cancer.

Interventions

Trade Name: Perjeta Product Name: Pertuzumab (rhuMAb 2C4) Product Code: RO4368451/F01 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Pertuzumab CAS Number: 380610-27-5

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Age >= 18 years ? Eastern Cooperative Oncology Group (ECOG) performance status 0-1 ? Intact skin at planned site of SC injections ? Left ventricular ejection fraction (LVEF) >= 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 ? 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 to avoid exposing the embryo Disease-specific Inclusion Criteria ? Female and male participants with stage II-IIIC early or locally advanced/inflammatory HER2+ breast cancer. ? Primary tumor > 2 cm in diameter, or node-positive disease ? HER2+ breast cancer confirmed by a local laboratory prior to study enrollment ? 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 ? 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 ==65 years) yes F.1.3.1 Number of subjects for this age range 132

Exclusion criteria

Exclusion criteria: ? Stage IV breast cancer ? History of concurrent or previously treated non-breast malignancies ? 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 optimize the anticoagulation dose and/or have not normalized their International Normalized Ratio (INR) ? Serious cardiac illness or medical conditions ? History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias ? Inadequate bone marrow function ? Impaired liver function ? Renal function with creatinine clearance 1.5 x Upper limit of normal (ULN) ? Major surgical procedure unrelated to breast cancer within 28 days prior to study entry or anticipation of the need for major surgery during the course of study treatment ? Current severe, uncontrolled systemic disease that may interfere with planned treatment ? Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the study ? Known active liver disease, for example, active viral hepatitis infection, autoimmune hepatic disorders, or sclerosing cholangitis ? Known hypersensitivity to any of the study drugs, excipients, and/or murine proteins or a history of severe allergic or immunological reactions, e.g., difficult to control asthma ? Current chronic daily treatment with corticosteroids ? Assessment by the investigator as being unable or unwilling to comply with the requirements of the protocol Cancer-specific Exclusion Criteria for Neoadjuvant Phase ? Participants who have received any previous systemic therapy for treatment or prevention of breast cancer, or radiation therapy for the treatment of cancer ? Participants who have a past history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) if they have received any systemic therapy for its treatment or radiation therapy to the ipsi- or contralateral breast cancer ? Participants with high-risk for breast cancer who have received chemopreventive drugs in the past are not allowed to enter the study ? Participants with multicentric breast cancer, unless all tumors are HER2+ ? Participants with bilateral breast cancer ? Participants who have undergone an excisional biopsy of primary tumor and/or axillary lymph nodes ? Axillary lymph node dissection (ALND) prior to initiation of neoadjuvant therapy ? Sentinel lymph node biopsy (SLNB) prior to neoadjuvant therapy

Design outcomes

Primary

Measure	Time frame
Main Objective: ? To evaluate patient preference of pertuzumab and trastuzumab (PH) fixed-dose combination (FDC) for subcutaneous (SC) administration in the home setting during the cross-over period of the adjuvant phase of the study;Secondary Objective: ? To evaluate the perception of healthcare professionals (HCPs) of time/resource use and convenience of PH FDC SC compared to PH IV during the neoadjuvant phase of the study ? Collect pathological complete response (pCR) data post-surgery ? To evaluate Health-related Quality of Life (HRQoL) during the neoadjuvant phase of the study and ? With PH FDC SC administered during the adjuvant phase of the study ? Evaluate the perception of HCPs of time/resource use of PH FDC SC during adjuvant cross-over period ? Evaluate HRQoL for participants treated with trastuzumab emtansine IV during the adjuvant phase ? Evaluate the safety and tolerability of PH FDC SC and P+H IV during neoadjuvant phase of the study ? Evaluate the safety and tolerability of PH FDC SC administered in the home setting and hospital setting during the cross-over period and the entire adjuvant treatment period ? Evaluate the safety and tolerability of trastuzumab emtansine IV during the adjuvant phase of the study;Primary end point(s): 1. Proportion of participants who preferred the administration of PH FDC SC in the home setting compared with the hospital setting in Question 1 of Patient Preference Questionnaire (PPQ);Timepoint(s) of evaluation of this end point: 1. At the end of cross over period on Day 1, Cycle 8 of adjuvant phase	—

Measure

Time frame

Main Objective: ? To evaluate patient preference of pertuzumab and trastuzumab (PH) fixed-dose combination (FDC) for subcutaneous (SC) administration in the home setting during the cross-over period of the adjuvant phase of the study;Secondary Objective: ? To evaluate the perception of healthcare professionals (HCPs) of time/resource use and convenience of PH FDC SC compared to PH IV during the neoadjuvant phase of the study ? Collect pathological complete response (pCR) data post-surgery ? To evaluate Health-related Quality of Life (HRQoL) during the neoadjuvant phase of the study and ? With PH FDC SC administered during the adjuvant phase of the study ? Evaluate the perception of HCPs of time/resource use of PH FDC SC during adjuvant cross-over period ? Evaluate HRQoL for participants treated with trastuzumab emtansine IV during the adjuvant phase ? Evaluate the safety and tolerability of PH FDC SC and P+H IV during neoadjuvant phase of the study ? Evaluate the safety and tolerability of PH FDC SC administered in the home setting and hospital setting during the cross-over period and the entire adjuvant treatment period ? Evaluate the safety and tolerability of trastuzumab emtansine IV during the adjuvant phase of the study;Primary end point(s): 1. Proportion of participants who preferred the administration of PH FDC SC in the home setting compared with the hospital setting in Question 1 of Patient Preference Questionnaire (PPQ);Timepoint(s) of evaluation of this end point: 1. At the end of cross over period on Day 1, Cycle 8 of adjuvant phase

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Secondary

Measure	Time frame
Secondary end point(s): 1. Responses of HCPs to the Healthcare Professional Questionnaire (HCPQ) by individual questions in the neoadjuvant phase 2. Proportion of participants achieving pCR, defined as eradication of invasive disease in the breast and axilla (i.e., ypT0/Tis ypN0), according to local pathologist assessment following the AJCC criteria 3. HRQoL assessed by European Organization for Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ)-C30 scores in the neoadjuvant phase 4. HRQoL assessed by EORTC QLQ-C30 scores in the participants treated with PH FDC SC during the adjuvant phase 5. Responses of HCPs to the HCPQ by individual questions in the adjuvant cross-over period 6. HRQoL assessed by EORTC QLQ-C30 scores in the participants treated with trastuzumab emtansine IV during the adjuvant phase 7. Incidence, nature and severity of all Adverse events (AEs), Grade >= 3 AEs, Serious adverse event (SAEs), and cardiac AEs (including LVEF events) with severity determined according to National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) v5.0 8. Incidence of premature withdrawal from the neoadjuvant treatment with PH FDC SC and P+H IV 9. Incidence of premature withdrawal from the adjuvant treatment with PH FDC SC 10. Incidence of premature withdrawal from the treatment with trastuzumab emtansine IV 11. Targeted vital signs and Physical findings 12. Targeted clinical laboratory test results;Timepoint(s) of evaluation of this end point: 1. HCPQs Neoadjuvant phase: Day 1 of Cycle 1 up to 5 or 7 (depends on chosen neo scheme) for question 1; Day 1 of the last cycle (6 or 8) for the rest 2. Post-surgery 3. Day 1 of Cycle 1 and last cycle (6 or 8, depends on chosen neoadjuvant scheme) 4. Those with pCR: Day 1 of Cycle 1, 3, 5, 8 and last cycle 5. HCPQs Adjuvant phase: Day 1 of Cycle 5 and 8 for question 1; Day 1 of Cycle 8 for the rest 6. Those without pCR (Arm E): Day 1 of Cycle 1, 7 and 14 7. Up to 6 to 9 m	—

Measure

Time frame

Secondary end point(s): 1. Responses of HCPs to the Healthcare Professional Questionnaire (HCPQ) by individual questions in the neoadjuvant phase 2. Proportion of participants achieving pCR, defined as eradication of invasive disease in the breast and axilla (i.e., ypT0/Tis ypN0), according to local pathologist assessment following the AJCC criteria 3. HRQoL assessed by European Organization for Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ)-C30 scores in the neoadjuvant phase 4. HRQoL assessed by EORTC QLQ-C30 scores in the participants treated with PH FDC SC during the adjuvant phase 5. Responses of HCPs to the HCPQ by individual questions in the adjuvant cross-over period 6. HRQoL assessed by EORTC QLQ-C30 scores in the participants treated with trastuzumab emtansine IV during the adjuvant phase 7. Incidence, nature and severity of all Adverse events (AEs), Grade >= 3 AEs, Serious adverse event (SAEs), and cardiac AEs (including LVEF events) with severity determined according to National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) v5.0 8. Incidence of premature withdrawal from the neoadjuvant treatment with PH FDC SC and P+H IV 9. Incidence of premature withdrawal from the adjuvant treatment with PH FDC SC 10. Incidence of premature withdrawal from the treatment with trastuzumab emtansine IV 11. Targeted vital signs and Physical findings 12. Targeted clinical laboratory test results;Timepoint(s) of evaluation of this end point: 1. HCPQs Neoadjuvant phase: Day 1 of Cycle 1 up to 5 or 7 (depends on chosen neo scheme) for question 1; Day 1 of the last cycle (6 or 8) for the rest 2. Post-surgery 3. Day 1 of Cycle 1 and last cycle (6 or 8, depends on chosen neoadjuvant scheme) 4. Those with pCR: Day 1 of Cycle 1, 3, 5, 8 and last cycle 5. HCPQs Adjuvant phase: Day 1 of Cycle 5 and 8 for question 1; Day 1 of Cycle 8 for the rest 6. Those without pCR (Arm E): Day 1 of Cycle 1, 7 and 14 7. Up to 6 to 9 m

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Countries

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

Contacts

Public ContactTrial Information Support Line-TISL

F. Hoffmann-La Roche Ltd

spain.start_up_unit@roche.com+34 637 32 02 90

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026