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 because the information has not been verified recently.
Verified November 2004 by Genentech, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00097487
First received: November 24, 2004
Last updated: June 23, 2005
Last verified: November 2004

November 24, 2004
June 23, 2005
November 2000
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Complete list of historical versions of study NCT00097487 on ClinicalTrials.gov Archive Site
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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.

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Observational
Observational Model: Defined Population
Time Perspective: Longitudinal
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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.
 
Active, not recruiting
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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00097487
H2251n
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Genentech, Inc.
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Genentech, Inc.
November 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP