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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
Information provided by:
Genentech, Inc. Identifier:
First received: November 24, 2004
Last updated: June 23, 2005
Last verified: November 2004
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 Phase
Breast Cancer Metastases Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Genentech, Inc.:

Estimated Enrollment: 1000
Study Start Date: November 2000
Estimated Study Completion Date: September 2004

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
  Contacts and Locations
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, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information Identifier: NCT00097487     History of Changes
Other Study ID Numbers: H2251n
Study First Received: November 24, 2004
Last Updated: June 23, 2005

Keywords provided by Genentech, Inc.:
Metastatic Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents processed this record on September 19, 2017