NCT00097487CompletedNot Applicable
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
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Genentech, Inc.
- Enrollment
- 1,000
Study Overview
Brief Summary
This study is a Phase IV, prospective, nonrandomized, community-based study of clinical outcomes in patients with metastatic breast cancer treated with Herceptin and a taxane.
Study Design
- Study Type
- Observational
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Investigators
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