Clinical Outcomes in Patients With HER2 Gene-Amplified Metastatic Breast Cancer Treated With First Line Herceptin in Combination With a Taxane: A Phase IV, Prospective, Community Based Study
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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