HER2-positive early breast cancer MedDRA version: 20.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Herceptin for SC injection with single use injection device
Product Code: Ro0452317/F07
Pharmaceutical Form: Solution for injection
INN or
Sponsors
Roche Nederland B.V.
Eligibility
Sex/Gender
All
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+ ISH positive or MLPA 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 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 113 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
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. Use of hormonal IUDs is up to discretion of the physician. 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 |
|---|---|
| Main Objective: To assess the overall safety and tolerability of subcutanous (SC) trastuzumab in HER2-positive early breast cancer (EBC) patients with using a single-use injection device (SID).;Secondary Objective: PK analysis of self-administration at home, patient reported outcomes and proportion of patients choosing to return to hospital administration.; Primary end point(s): Adverse Event (AE) collection will be the primary endpoint for this study. Summaries will include: - 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 ;Timepoint(s) of evaluation of this end point: The primary analysis of the safety endpoints will take place when all patients have received 18 cycles of trastuzumab SC and have completed the safety follow-up assessments | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: The secondary analysis of the safety endpoints will take place when all patients have received 18 cycles of trastuzumab SC and have completed the safety follow-up assessments; Secondary end point(s): Secondary safety assessments will include the following: o Exposure to study medication o Duration of treatment, follow-up, and safety observation o ECOG o Concomitant medications o Laboratory data, vital signs and physical examination o Premature withdrawals and major protocol violations | — |
Countries
Netherlands
Contacts
Public ContactIris Schaafsma
Roche Netherlands B.V.
Outcome results
None listed