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


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N/A
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Retrospective

Principal Investigator

Elizabeth Tan-Chiu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Reserach Network, Inc.

Authority:

United States: Institutional Review Board

Study ID:

H2933s

NCT ID:

NCT00153218

Start Date:

June 2004

Completion Date:

Related Keywords:

  • Breast Cancer
  • Metastatic Breast Cancer
  • Her2neu
  • trastuzumab
  • Breast Neoplasms

Name

Location

Cancer Research Network, Inc.Plantation, Florida  33324
University of Pittsburgh Cancer Institute Magee-Womans HospitalPittsburgh, Pennsylvania  15213