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

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ClinicalTrials.gov Identifier: NCT00097487
Recruitment Status : Unknown
Verified November 2004 by Genentech, Inc..
Recruitment status was:  Active, not recruiting
First Posted : November 25, 2004
Last Update Posted : June 24, 2005
Information provided by:
Genentech, Inc.

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.

Condition or disease Phase
Breast Cancer Metastases Phase 4

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: 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
Study Start Date : November 2000
Estimated Study Completion Date : September 2004

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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

ClinicalTrials.gov Identifier: NCT00097487     History of Changes
Other Study ID Numbers: H2251n
First Posted: November 25, 2004    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: November 2004

Keywords provided by Genentech, Inc.:
Metastatic Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents