An Open-label, Randomized, Multicenter Phase III Study in Patients With HER2-positive Metastatic Breast Cancer Responding to First Line Treatment With Intravenous Trastuzumab for at Least 3 Years and Investigating Patient Preference for Subcutaneous Trastuzumab
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Histologically or cytologically confirmed HER2-positive metastatic breast cancer
- On treatment with first-line Herceptin IV and free of disease progression for at
least 3 years
- Left ventricular ejection fraction (LVEF) of >/= 50%
- Hormonal therapy will be allowed
- Prior use of anti-HER2 therapy will be allowed
Exclusion Criteria:
- History of other malignancy, except for 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; patients with previous
ductal carcinoma in situ of the breast are also eligible
- Patients with severe dyspnea at rest or requiring supplementary oxygen therapy
- Serious cardiac illness or medical conditions that would preclude the use of
Herceptin
- Hepatitis B, hepatitis C or HIV infection
- Pregnant or lactating women
- Concurrent enrolment in an other clinical trial using an investigational anti-cancer
treatment, including hormonal therapy, biphosphonate 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 subcutaneous device, or a
history of severe allergic or immunological reactions, e.g. difficult to control
asthma
- Central nervous system (CNS) metastases unless they have been treated and have been
stable for at least 3 months
- Inadequate organ function