Status:
COMPLETED
A Study of Patients With HER2 Gene Amplified Metastatic Breast Cancer Treated With First Line Herceptin and a Taxane
Lead Sponsor:
Genentech, Inc.
Conditions:
Breast Cancer
Metastases
Eligibility:
FEMALE
18+ years
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 30 2000
Trial Type :
OBSERVATIONAL
End Date :
September 30 2004
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT00097487
Start Date
November 30 2000
End Date
September 30 2004
Last Update
March 2 2018
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