A Study of Subcutaneously Administered Herceptin (Trastuzumab) in Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Trastuzumab - intravenous solution; Trastuzumab - subcutaneous solution; Chemotherapy
Intervention description: Trastuzumab was supplied as a powder to be reconstituted as a solution for intravenous infusion.; Trastuzumab was supplied as a solution for subcutaneous injection.; Standard chemotherapy for early breast cancer.
Intervention MeSH terms: Trastuzumab; Pharmaceutical Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, randomized crossover study evaluated the quality of life, efficacy, and
      safety of subcutaneous Herceptin (trastuzumab) injected either into the thigh or the upper
      arm of participants with early HER2-positive breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female and male patients ≥ years of age.

          -  HER2-positive early breast cancer.

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

          -  Hormonal therapy will be allowed as per institutional guidelines.

          -  Patients must be Herceptin (trastuzumab) naïve.

          -  Left ventricular ejection fraction (LVEF) of ≥ 55%.

          -  Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast.

          -  No evidence of residual, locally recurrent, or metastatic disease after completion of
             surgery and chemotherapy, or during concurrent 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. 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.

          -  Patients with severe dyspnea at rest or requiring supplementary oxygen therapy.

          -  Patients 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
             Herceptin, specifically, a 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), or diagnosed poorly controlled hypertension.

          -  Pregnant or lactating women.

          -  Women of childbearing potential and male patients 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 a history of severe allergic or immunological
             reactions, eg, difficult to control asthma.

          -  Inadequate bone marrow, hepatic, or renal function.