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
  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

Genders 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
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.

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, Inc.
Investigators
Principal Investigator: Elizabeth Tan-Chiu, MD Cancer Reserach Network, Inc.
  More Information

No publications provided

Responsible Party: Cancer Research Network
ClinicalTrials.gov Identifier: NCT00153218     History of Changes
Other Study ID Numbers: H2933s, CRN006
Study First Received: September 7, 2005
Last Updated: February 13, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 29, 2014