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

NCT ID: NCT00153218

Last Updated: 2012-02-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 94 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-06-30

Brief Summary

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.

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Eligibility 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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Cancer Research Network

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth Tan-Chiu, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Reserach Network, Inc.

Locations

Cancer Research Network, Inc.

Plantation, Florida, United States

University of Pittsburgh Cancer Institute Magee-Womans Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

CRN006

Identifier Type: -

Identifier Source: secondary_id

H2933s

Identifier Type: -

Identifier Source: org_study_id