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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00153218
First Posted: September 12, 2005
Last Update Posted: February 14, 2012
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.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Cancer Research Network
  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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: An Observational Study of Current Practice Pattern on the Treatment of Women With Metastatic Breast Cancer Whose Tumors Overexpress Her2neu

Resource links provided by NLM:


Further study details as provided by Cancer Research Network:

Enrollment: 94
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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Her-2-neu positive breast cancer patients
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, Inc.
Investigators
Principal Investigator: Elizabeth Tan-Chiu, MD Cancer Reserach Network, Inc.
  More Information

Responsible Party: Cancer Research Network
ClinicalTrials.gov Identifier: NCT00153218     History of Changes
Other Study ID Numbers: H2933s
CRN006
First Submitted: September 7, 2005
First Posted: September 12, 2005
Last Update Posted: February 14, 2012
Last Verified: February 2012

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases