None listed
Conditions
Interventions
Patients will be randomized (1:1) to either trastuzumab-Pfizer plus paclitaxel or trastuzumab-EU plus paclitaxel. Randomization will be stratified by prior adjuvant trastuzumab exposure (yes versus n
Sponsors
PFIZER S.A.,
Eligibility
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Patient eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before patients are included in the study. Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1. Female patients aged 18 years or older. (Where required by regulations, consent from a legally acceptable representative is required for all patients who are younger than 20 years of age.) 2. Histologically confirmed diagnosis of breast cancer. 3. Presence of metastatic disease. 4. Prior documentation of HER2 gene amplification or overexpression by one of the following: a. Gene amplification by fluorescent in-situ hybridization (FISH) or chromogenic in-situ hybridization (CISH) (as defined by the manufacturer’s kit instruction); OR b. Overexpression by immunohistochemistry (IHC) categorized as IHC3+; OR c. Overexpression by immunohistochemistry categorized as IHC2+ with FISH or CISH confirmation. Determination of HER2 positive status using one of the Sponsor accepted analytical test methods must be documented in the patient’s source documentation. If HER2 status is unavailable or was determined using a test other than a Sponsor-approved assay, eligibility must be documented by the Sponsor-provided central laboratory prior to randomization. 5. Available tumor tissue (ie, formalin fixed paraffin embedded blocks or unstained slides) for central review of HER2 status. Tumor tissue should be from metastatic disease or, if not obtainable, may be from the primary tumor at the time of diagnosis..... (see the file)
Exclusion criteria
Exclusion criteria: Patients presenting with any of the following will not be included in the study: 1. Patients who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or patients who are Pfizer employees directly involved in the conduct of the trial. 2. Relapse within 1 year of last dose of previous adjuvant (including neoadjuvant) treatment. 3. Prior systemic therapy for metastatic disease (except endocrine therapy). 4. Prior cumulative dose of doxorubicin of >400 mg/m2, epirubicin dose >800 mg/m2, or the equivalent dose for other anthracyclines or derivatives (e.g., 72 mg/m2 of mitoxantrone). If the patient has received more than one anthracycline, then the cumulative dose must not exceed the equivalent of 400 mg/m2 of doxorubicin. 5. Inflammatory breast cancer. 6. Superficial disease site that cannot be assesed...(see the file)
Countries
Argentina, Brazil, Canada, Chile, Czech Republic, Greece, Hungary, India, Italy, Japan, Korea South, Mexico, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, South Africa, Spain, Thailand, Turkey, Ukraine, United States
Outcome results
None listed