TO INVESTIGATE THE AT HOME ADMINISTRTATION OF TRASTUZUMAB SUBCUTANEOUS VIAL FOR THE TREATMENT OF PATIENTS WITH HER2-POSITIVE EARLY BREAST CANCER.
Conditions
Interventions
Product Name: Trastuzumab
Product Code: Ro 045-2317/F07
Pharmaceutical Form: Solution for injection
INN or Proposed INN: TRASTUZUMAB
CAS Number: 180288-69-1
Concentration unit: mg/ml milligram(s)/mill
Sponsors
NV ROCHE SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female and male patients aged = 18 years 2. Signed informed consent prior to any study specific procedure 3. Able and willing to comply with protocol 4. Eastern Cooperative Oncology Group (ECOG) performance status 0–1 5. Hormonal therapy will be allowed as per institutional guidelines 6. Left ventricular ejection fraction (LVEF) of = 50% measured by echocardiography (ECHO) or multiple gated acquisition (MUGA) scan prior to first dose of trastuzumab SC, or, for those who were receiving trastuzumab when beginning the study, documented results within an acceptable limit from a cardiac assessment within 3 months prior to enrolment 7. HER2-positive disease immunohistochemistry (IHC)3+ or in situ hybridization (ISH) positive, in line with local reimbursement criteria and determined in a local laboratory that is experienced/certified in HER2-expression testing using an accurate and validated assay 8. Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast 9. No evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy, or during concurrent chemotherapy (neo-adjuvant or adjuvant) 10. Use of concurrent curative radiotherapy will be permitted 11. Patients have completed the first 6 cycles of trastuzumab IV as part of the (neo)adjuvant treatment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. History of other malignancy which could affect compliance with the protocol or interpretation of results. Patients with curatively treated carcinoma in situ of the cervix or basal cell carcinoma, and patients with other curatively treated malignancies who have been disease-free for at least 5 years, are eligible 2. Patients with severe dyspnea at rest or requiring supplementary oxygen therapy 3. Patients with other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness 4. Serious cardiac illness or medical conditions that would preclude the use of trastuzumab, specifically: history of documented congestive heart failure (CHF), high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ECG), diagnosed poorly controlled hypertension 5. Known infection with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus (HCV) 6. Pregnant or lactating women. Positive serum pregnancy test in women of childbearing potential, premenopausal or less than 12 months of amenorrhea post-menopause, within 7 days prior to the first dose of study drug 7. Women of childbearing potential, premenopausal or less than 12 months of amenorrhea post-menopause (unless surgically sterile), and male patients with partners of childbearing potential who are unable or unwilling to use adequate contraceptive measures during study treatment. In this study, menopause is defined as a minimum of 12 consecutive months of amenorrhea during which time no other biological or physiological cause had been identified as a potential cause of this state. Examples of adequate contraceptive measures are intrauterine device, barrier method (condoms, diaphragm) also in conjunction with spermicidal jelly, or total abstinence. Oral, injectable, or implant hormonal contraceptives are not acceptable 8. Concurrent enrolment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, bisphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment 9. Known hypersensitivity to trastuzumab, murine proteins, to any of the excipients of Herceptin® including hyaluronidase, or the adhesive of the SC device, or a history of severe allergic or immunological reactions, e.g. difficult to control asthma 10. Patients assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol 11. Inadequate bone marrow function (as indicated by any of the following): a) Absolute neutrophil count (ANC) 1.5 × upper limit of normal (ULN) b) Alanine amino transferase (ALT) and/or aspartate amino transferase (AST) > 2.5 × ULN c) Alkaline phosphatase (ALP) > 2.5 × ULN 13. Inadequate renal function, as indicated by serum creatinine > 1.5 × ULN
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the overall safety and tolerability of subcutaneous (SC) trastuzumab with assisted administration using a conventional syringe and needle (vial formulation, hereafter referred to as trastuzumab SC vial) when administered at home for the treatment of patients with HER2-positive (HER2+) early breast cancer (eBC). Secondary Objectives To describe: • Patient experience with trastuzumab IV administered in the hospital. • Patient experience with trastuzumab SC vial administered in the hospital. • Patient experience with trastuzumab SC vial administered at home. • Patient reporting of symptoms. • Patient reporting on the quality of care provided in the hospital and at home. • HCP overall satisfaction and perceived time savings with trastuzumab SC vial formulation administered in the hospital. • Disease-free survival (DFS). ;Secondary Objective: To describe: • Patient experience with trastuzumab IV administered in the hospital. • Patient experience with trastuzumab SC vial administered in the hospital. • Patient experience with trastuzumab SC vial administered at home. • Patient reporting of symptoms. • Patient reporting on the quality of care provided in the hospital and at home. • HCP overall satisfaction and perceived time savings with trastuzumab SC vial formulation administered in the hospital. • Disease-free survival (DFS). ;Primary end point(s): Safety Outcome Measures Adverse event (AE) collection will be the primary endpoint for the study. Incidence and severity by NCI CTCAE version 4.0 of AEs and serious adverse events (SAEs) • AEs leading to premature discontinuation of study treatment • Cardiac safety o Cardiac AEs o CHF (according to NCI CTCAE version 4.0 and New York Heart Association [NYHA] Classification) o LVEF over time. In the event of an asymptomatic decline in LVEF, an algorithm (Appendix 2 in the protocol) will be used to determine whether to continue trastuzumab SC treatment • Secondary | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: The secondary analyses of patients’ experience, patient reporting of symptoms and health care professional experience and overall satisfaction will be undertaken once all patients have completed the study treatment phase and safety follow-up 4 weeks after their last dose of study treatment) Details will be described in the statistical analysis plan that will be finalized before data base lock. ;Secondary end point(s): Patient-Reported Outcome Measures • Patient experience with the treatment provided during the in-hospital part of the study: Patients will be asked to complete a questionnaire (PSQ1, appendix 6) related to the quality of care provided during trastuzumab administration in the hospital prior to the first dose trastuzumab SC vial administered at home = prior to cycle13. • Patient experience with the treatment provided during the at home part of the study: Patients will be asked to complete a questionnaire (PSQ2, appendix 6) related to the quality of care provided during trastuzumab SC vial administration at home prior to the fifth dose trastuzumab SC vial administered at home = prior to cycle 17. • Patient reporting of symptoms using the MD Anderson Symptom Inventory (MDASI, appendix 4): Patients will be asked to rate the severity of 13 core items on a scale from 0 to 10. Patients will be asked to complete the MDASI 4 times: Prior to the first dose trastuzumab IV = prior to cycle 7, prior to the first dose trastuzumab SC vial = prior to cycle 10, prior to the first dose trastuzumab SC vial administered at home = prior to cycle 13 and prior to the fourth dose trastuzumab SC vial administered at home = prior to cycle 16. HCP-Reported Outcome Measures • HCP overall satisfaction and perceived time savings with trastuzumab SC vial in the hospital will be assessed by a Health Care Professional Questionnaire (HCPEX-1, appendix 5): The HCPEX-1 questionnaire will be completed by a HCP administering trast | — |
Countries
Belgium, Israel
Contacts
Public ContactCLINICAL STUDY MANAGER
NADIA DEBDI
Outcome results
None listed