Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Signed informed consent
Available tissue for central laboratory evaluation of HER2 status
Histologically confirmed, measurable or nonmeasurable but evaluable, HER2 positive metastatic breast cancer (HER2 positive is defined as 3+ staining by IHC or gene amplification by FISH, determined by the local or central laboratory)
Life expectancy \>6 months
Female, age \>=18 years
ECOG performance status of 0, 1, or 2
Adequate bone marrow function as indicated by the following: \*ANC \>1500/uL, \*Platelet count \>=100,000/uL
Adequate renal function, as indicated by creatinine \<=1.5× upper limit of normal (ULN)
Adequate liver function, as indicated by bilirubin \<=1.5× ULN and AST or ALT \<2× ULN unless related to primary disease
Use of an adequate means of birth control (women of childbearing potential)
You may not be if
Initiation of Herceptin \>=4 weeks after beginning taxane chemotherapy
Prior chemotherapy for metastatic disease
Prior cumulative anthracycline dose of \>360 mg/m2
History of significant cardiac disease or uncontrolled arrhythmias
Ejection fraction of \<50% or below the lower limit of normal
Active infection
Symptomatic or untreated brain metastases
Pregnancy or lactation
Concomitant malignancies or previous malignancies within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs, resulting in dyspnea at rest
Hypersensitivity to study medications
Major organ failure or systemic disease precluding the safe administration of study medications
Clareo Health | A Study of Patients With HER2 Gene Amplified Metastatic Breast Cancer Treated With First Line Herceptin and a Taxane
