A Study of Subcutaneous At Home Administration of Trastuzumab (Herceptin) in Participants With Human Epidermal Growth Factor Receptor 2-positive (HER2+) Early Breast Cancer (eBC)
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Trastuzumab
Intervention description: Trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w; Trastuzumab 600 mg q3w SC injection will be administered as per the schedule specified in the arm.
Intervention MeSH terms: Trastuzumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm, multicenter study will evaluate the safety of assisted subcutaneous
      administration of trastuzumab in participants with HER2+ eBC. Participants who have completed
      the first 6 cycles of intravenous (IV) trastuzumab as part of the (neo)adjuvant treatment
      will be eligible to receive a further 12 cycles of trastuzumab in this study. Participants
      will receive IV trastuzumab at initial loading dose of 8 milligrams per kilogram (mg/kg) body
      weight (BW) for three-weekly (q3w) regimen and then recommended maintenance dose of 6 mg/kg
      BW q3w for the first 3 cycles (cycles 7-9) in hospital followed by subcutaneous (SC)
      administration of trastuzumab at a fixed dose of 600 mg q3w for next 3 cycles (Cycles 10-12)
      at hospital and SC administration of trastuzumab at a fixed dose of 600 mg q3w at home for
      the next 6 cycles (Cycles 13-18).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast

          -  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

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1

          -  Hormonal therapy will be allowed as per institutional guidelines

          -  Left ventricular ejection fraction (LVEF) of greater than or equal to (>/=) 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 enrollment

          -  Participants have completed the first 6 cycles of trastuzumab IV as part of the
             (neo)adjuvant treatment

          -  No evidence of residual, locally recurrent or metastatic disease after completion of
             surgery and chemotherapy, (neo-adjuvant or adjuvant)

          -  Use of concurrent curative radiotherapy will be permitted

        Exclusion Criteria:

          -  History of other malignancy which could affect compliance with the protocol or
             interpretation of results. Participants 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

          -  Participants with severe dyspnea at rest or requiring supplementary oxygen therapy

          -  Participants with other concurrent serious diseases that may interfere with planned
             treatment, including severe pulmonary conditions/illness

          -  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

          -  Known infection with human immunodeficiency virus (HIV), active hepatitis B virus
             (HBV) or hepatitis C virus (HCV)

          -  Pregnant or lactating women

          -  Women of childbearing potential and male participants with partners of childbearing
             potential who are unable or unwilling to use adequate contraceptive measures during
             study treatment

          -  Concurrent enrollment 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

          -  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

          -  Inadequate bone marrow, hepatic or renal function