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A Study of Patients With HER2 Gene Amplified Metastatic Breast Cancer Treated With First Line Herceptin and a Taxane

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2004 by Genentech, Inc..
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00097487
First Posted: November 25, 2004
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Genentech, Inc.
November 24, 2004
November 25, 2004
December 9, 2005
November 2000
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No Changes Posted
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A Study of Patients With HER2 Gene Amplified Metastatic Breast Cancer Treated With First Line Herceptin and a Taxane
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
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.
Not Provided
Observational
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
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  • Breast Cancer
  • Metastases
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
1000
September 2004
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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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00097487
H2251n
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Genentech, Inc.
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Genentech, Inc.
November 2004