breast cancer HER-2 positive breast cancer
Conditions
Interventions
The investigational medicinal product for this study is trastuzumab SC 600 mg,
supplied as a SID formulation.
Patients in this local study will receive a fixed dose of 600 mg trastuzumab SC
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Sponsors
Roche Nederland B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Female and male patients aged * 18 years 2. Eastern Cooperative Oncology Group (ECOG) performance status 0*1 3. Hormonal therapy will be allowed as per institutional guidelines 4. Prior use of anti-HER2 therapy in combination with chemotherapy will be allowed 5. 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.Except in case patient received anthracycline treatment previously then documented results within an acceptable limit from a cardiac assessment within 14 days prior to enrolment. 6. HER2-positive disease immunohistochemistry (IHC)3+ or in situ hybridization (ISH) positive as determined in a local laboratory that is experienced/certified in HER2-expression testing using an accurate and validated assay 7. Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast 8. No evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy, or during concurrent chemotherapy (neo-adjuvant or adjuvant) 9. Use of concurrent curative radiotherapy will be permitted 10. Completion of surgery and chemotherapy (if applicable) for eBC
Exclusion criteria
Exclusion criteria: 1. History of other malignancy which could affect compliance with the protocol or interpretation of results. 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 4. Serious cardiac illness or medical conditions that would preclude the use of trastuzumab 5. Pregnant or lactating women. 6. 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 7. 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 8. 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 9.Patients assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol 10. Impaired hepatic function 11. Inadequate renal function
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective The primary objective of this study is to assess the overall safety and tolerability of subcutaneous (SC) trastuzumab using SID in HER2-positive eBC patients self-administered at home under supervision of trained HCP. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives The secondary objectives of this study are PK analysis of self-administration at home, patient reported outcomes and proportion of patients choosing to return to hospital administration. Exploratory Objective To assess efficacy (disease-free survival and overall survival data) | — |
Countries
Netherlands
Outcome results
None listed