None listed
Conditions
Interventions
Dose, route, frequency: 8 mg/kg loading dose at the start of treatment by continuous intravenous (I.V.) infusion over 90 min (± 10 minutes). Thereafter, (beginning 3 weeks after the loading dose) 6 mg
Sponsors
Mylan GmbH,
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. ≥18 years of age. 2. Histologically confirmed diagnosis of breast cancer. 3. Locally recurrent or MBC that is not amenable to curative surgery and/or radiation. 4. Documentation of HER2 gene amplification by fluorescent in situ hybridization (FISH) (as defined by a ratio >2.0) or documentation of HER2-overexpression by immunohistochemistry (IHC) (defined as IHC3+, or IHC2+ with FISH confirmation) based on the sponsor-identified central laboratory prior to randomization. Archival tumor tissue samples can be used. 5. Documentation of estrogen receptor/progesterone receptor (ER/PgR) status (positive or negative) based on either a local or central laboratory report must be available before randomization.
Exclusion criteria
Exclusion criteria: 1. Prior systemic therapy in the metastatic disease setting. This includes: chemotherapy, signal transduction inhibitors (e.g., lapatinib), HER2 targeted therapy (e.g., trastuzumab), or other investigational anticancer therapy. 2. Prior treatment with neoadjuvant or adjuvant anthracyclines with a cumulative dose of doxorubicin of >400 mg/m2, epirubicin dose >800 mg/m2. 3. Participation in the active treatment phase of an investigational drug study ≤28 days prior to randomization. 4. Patients with bone or skin as the only site of disease. Patients with skin lesions measurable by CT scans or MRI as only site of measurable disease are allowed. 5. Surgery or radiotherapy ≤2 weeks preceding Day 1. Target lesions have to be outside the irradiated fields and the patient has fully recovered from surgery or radiotherapy.
Countries
Argentina, Austria, Brazil, Bulgaria, Chile, Czech Republic, Egypt, France, Georgia, Germany, Greece, Hungary, India, Italy, Latovia, Mexico, Peru, Philippines, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Thailand, Turkey, Ukraine
Contacts
Public ContactMarcela Toledo
SYNEOS HEALTH PERU S.R.L.
Outcome results
None listed