Herceptin (Trastuzumab) in Treating Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Primary Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Herceptin; Herceptin
Intervention description: Herceptin will be given as a loading dose of 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks.; Herceptin will be given as a loading dose of 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks.
Intervention MeSH terms: Trastuzumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 5099.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this trial is to evaluate Herceptin treatment for 1 year and 2 years (versus
      observation/no Herceptin) in women with HER2-overexpressing primary breast cancer who have
      completed (neo-)adjuvant systemic chemotherapy, definitive surgery, and radiotherapy, if
      applicable. Efficacy and safety will be assessed for 10 years from randomization for each
      participant. All participants will continue to be followed for survival until 10 years after
      enrollment of the last participant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-metastatic primary invasive breast cancer overexpressing HER2 (determined by
             immunohistochemistry 3+ or positive fluorescence in situ hybridization test) that has
             been histologically confirmed, adequately excised, axillary node positive or negative,
             and tumor size at least T1c according to Tumor/Node/Metastasis (TNM) staging

          -  Completion of at least 4 cycles of (neo-)adjuvant systemic chemotherapy, definitive
             surgery, and radiotherapy, if applicable

          -  Known hormone receptor status

          -  Baseline left ventricular ejection fraction (LVEF) greater than or equal to (≥) 55
             percent (%)

        Exclusion Criteria:

          -  Prior invasive breast carcinoma

          -  Other malignancies except for curatively treated basal and squamous cell carcinoma of
             the skin or in situ carcinoma of the cervix

          -  Clinical T4 tumors

          -  Cumulative doxorubicin exposure greater than (>) 360 milligrams per meter-squared
             (mg/m^2) or epirubicin >720 mg/m^2 or any prior anthracyclines unrelated to the
             present breast cancer

          -  Peripheral stem cell or bone marrow stem cell support

          -  Prior mediastinal irradiation except for internal mammary node irradiation for the
             present breast cancer

          -  Non-irradiated internal mammary nodes or supraclavicular lymph node involvement

          -  Prior anti-HER2 therapy for any other reason or other prior biologic or immunotherapy
             for breast cancer

          -  Concurrent anti-cancer treatment in another investigational trial

          -  Serious cardiac or pulmonary conditions/illness, or any other conditions that could
             interfere with planned treatment

          -  Poor hematologic, hepatic, or renal function

          -  Pregnancy or lactation

          -  Women of childbearing potential or less than 1 year post-menopause unwilling to use
             adequate contraceptive measures