Participant Preference of Subcutaneous (SC) Versus Intravenous (IV) Herceptin (Trastuzumab) in Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: Herceptin; Herceptin; Single-Use Injection Device; Single-Use Injection Device
Intervention description: Herceptin will be given on Day 1 of each 3-week cycle for a total of 18 cycles. If study treatment for Cycle 1 is IV Herceptin, the initial dose will be a loading dose of 8 milligrams per kilogram (mg/kg) for de novo participants who start Herceptin treatment in the study. For all other cycles where IV Herceptin is given and for non-de novo participants, the dose will be 6 mg/kg. The SC dose will be 600 milligrams (mg) for both the SID and vial formulations for all cycles where SC Herceptin is given.; Herceptin will be given on Day 1 of each 3-week cycle for a total of 18 cycles. If study treatment for Cycle 1 is IV Herceptin, the initial dose will be a loading dose of 8 mg/kg for de novo participants who start Herceptin treatment in the study. For all other cycles where IV Herceptin is given and for non-de novo participants, the dose will be 6 mg/kg. The SC dose will be 600 mg for both the SID and vial formulations for all cycles where SC Herceptin is given.; The SID will be used, containing Herceptin 600 mg per 5 milliliters (mL).; The SID will be used, containing Herceptin 600 mg per 5 mL.
Intervention MeSH terms: Trastuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 488.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized, open-label, crossover study will evaluate participants' preference and
      healthcare professional (HCP) satisfaction with SC versus IV Herceptin administration in
      HER2-positive early breast cancer. Participants will be randomized to receive either SC
      Herceptin or IV Herceptin every 3 weeks for Cycles 1 to 4, followed by crossover to the other
      treatment administration for Cycles 5 to 8. For up to 10 additional cycles (for a total of 18
      cycles), participants will receive IV or SC Herceptin every 3 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed HER2-positive primary breast cancer

          -  No evidence of residual, locally recurrent, or metastatic disease after completion of
             surgery and chemotherapy (neo-adjuvant or adjuvant)

          -  Completed neo-adjuvant chemotherapy prior to entry, if received

          -  At least 8 remaining cycles out of the total 18 planned 3-week cycles, if received IV
             Herceptin

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

        Exclusion Criteria:

          -  History of other malignancy, except for ductal carcinoma in situ of the breast,
             curatively treated carcinoma in situ of the cervix, basal cell carcinoma, or other
             curatively treated malignancies of which the participant has been disease-free for at
             least 5 years

          -  Inadequate bone marrow function

          -  Impaired liver function

          -  Inadequate renal function

          -  Serious cardiovascular disease

          -  Human immunodeficiency virus or hepatitis B or C infection

          -  Prior maximum cumulative dose of doxorubicin greater than (>) 360 milligrams per
             meter-squared (mg/m^2) or epirubicin >720 mg/m^2 or equivalent