An Observational Study of Current Practice Pattern on the Treatment of Women With Metastatic Breast Cancer Whose Tumors Overexpress Her2neu

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Cancer Research Network
ClinicalTrials.gov Identifier:
NCT00153218
First received: September 7, 2005
Last updated: February 13, 2012
Last verified: February 2012

September 7, 2005
February 13, 2012
June 2004
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Complete list of historical versions of study NCT00153218 on ClinicalTrials.gov Archive Site
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An Observational Study of Current Practice Pattern on the Treatment of Women With Metastatic Breast Cancer Whose Tumors Overexpress Her2neu
An Observational Study of Current Practice Pattern on the Treatment of Women With Metastatic Breast Cancer Whose Tumors Overexpress Her2neu

The purpose of this study is to observe clinical outcomes of metastatic breast cancer patients whose tumors overexpress the Her2neu protein and are being treated with trastuzumab (Herceptin)either alone or combination with chemotherapy or hormonal therapy.

In clinical practice, patients with metastatic breast cancer are being treated either with trastuzumab alone or trastuzumab in combination with chemotherapy or hormonal therapy as it has shown to increase survival. There is currently minimal information as to how long trastuzumab should be given after disease progresses on trastuzumab. This study is a chart review of the above-mentioned population which will capture information such as;

  • what chemo or hormonal therapies are chosen by clinicians for Her-2 positive metastatic patients to combine with trastuzumab
  • what the number of treatment regimens are (chemo or hormonal) given with trastuzumab
  • what the clinical outcome of patients treated is
  • what happens to the patients cardiac status with long term administration of trastuzumab
  • what treatment patterns exist in the management of central nervous system metastases

This study aims to generate a hypotheses that can be tested from the information collected after is has been analyzed to give clinicians further meaningful data to guide treatment decisions beyond treatment progression.

Observational
Observational Model: Case-Only
Time Perspective: Retrospective
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Non-Probability Sample

Her-2-neu positive breast cancer patients

Breast Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
94
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Inclusion Criteria:

  • patients must have metastatic breast cancer
  • tumor must have been determined to be Her-2 positive 3+ by immunohistochemistry or gene-amplified by fluorescence-in-situ hybridization (FISH)
  • must have received trastuzumab alone or in combination with chemotherapy or hormonal therapy
  • must not have received trastuzumab in the adjuvant or neoadjuvant setting
  • must have started trastuzumab treatment for metastatic disease any time between January 1996 to June 2003

Exclusion Criteria:

  • patients who received trastuzumab prior to 1996
Female
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00153218
H2933s, CRN006
Not Provided
Cancer Research Network
Cancer Research Network
Genentech, Inc.
Principal Investigator: Elizabeth Tan-Chiu, MD Cancer Reserach Network, Inc.
Cancer Research Network
February 2012

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