A clinical study, conducted in several sites in Belgium, investigating the administration at patient's home of the new subcutaneous formulation of the drug trastuzumab for treating patients suffering from a type of breast cancer at early stage, called HER2-positive early breast cancer.

Phase 1

Conditions: TO INVESTIGATE THE AT HOME ADMINISTRTATION OF TRASTUZUMAB SUBCUTANEOUS VIAL FOR THE TREATMENT OF PATIENTS WITH HER2-POSITIVE EARLY BREAST CANCER.
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2013-000123-13-BE

Lead Sponsor: V ROCHE SA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

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

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) < 1,500 / mm3 (< 1.5 × 109/L)
b)Platelets < 100,000 / mm3 (< 100 × 109/L)
Hemoglobin < 10 g/dL
12.Impaired hepatic function (as indicated by any of the following):
a)Serum total bilirubin > 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