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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.
Sponsors and Collaborators: Cancer Research Network
Genentech
Information provided by: Cancer Research Network
ClinicalTrials.gov Identifier: NCT00153218
  Purpose

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.


Condition
Breast Cancer

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Trastuzumab
U.S. FDA Resources
Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study
Official Title: An Observational Study of Current Practice Pattern on the Treatment of Women With Metastatic Breast Cancer Whose Tumors Overexpress Her2neu

Further study details as provided by Cancer Research Network:

Estimated Enrollment: 177
Study Start Date: June 2004
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00153218

Locations
United States, Florida
Cancer Research Network, Inc.
Plantation, Florida, United States, 33324
United States, Pennsylvania
University of Pittsburgh Cancer Institute Magee-Womans Hospital
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Cancer Research Network
Genentech
Investigators
Principal Investigator: Elizabeth Tan-Chiu, MD Cancer Reserach Network, Inc.
Principal Investigator: Adam Brufsky, MD University of Pittsburgh
  More Information

Study ID Numbers: H2933s, CRN006
Study First Received: September 7, 2005
Last Updated: September 9, 2005
ClinicalTrials.gov Identifier: NCT00153218  
Health Authority: United States: Institutional Review Board

Keywords provided by Cancer Research Network:
Metastatic Breast Cancer
Her2neu
trastuzumab

Study placed in the following topic categories:
Skin Diseases
Trastuzumab
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009