COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

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. Identifier: NCT00097487
Recruitment Status : Completed
First Posted : November 25, 2004
Last Update Posted : March 2, 2018
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
Breast Cancer Metastases

Layout table for study information
Study Type : Observational
Enrollment : 1000 participants
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
Actual Study Start Date : November 30, 2000
Actual Study Completion Date : September 30, 2004

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
Layout table for additonal information Identifier: NCT00097487    
Other Study ID Numbers: H2251n
First Posted: November 25, 2004    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: February 2018
Keywords provided by Genentech, Inc.:
Metastatic Breast Cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases