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An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer (VIRGO) - NCT00726661-53405(Clinical Trial 234583)



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City:  Racine
State:  
WI
Zip Code: 53405
Conditions: Breast Cancer
Purpose: This is a multicenter, prospective OCS designed to follow patients with locally recurrent or metastatic breast cancer in the United States. Two cohorts will be included: - Patients with HER2-normal disease receiving their first cytotoxic chemotherapy and/or targeted therapy (1500 patients) - Patients with HR-positive tumors receiving their first HT for advanced disease (500 patients) Patients who started their first systemic treatment for advanced breast cancer within 1 month prior to enrollment into this OCS will be eligible. A total of approximately 2000 patients will be enrolled. In order to assure that treatment patterns over time are represented in the study, the number of sites activated will be determined by projections to achieve complete enrollment over approximately 18-24 months.
Study summary:
Criteria: Inclusion Criteria: - Signed Informed Consent Form - Locally recurrent or metastatic breast cancer - Receipt of first systemic cytotoxic chemotherapy and/or targeted therapy among those with HER2-normal disease or first hormone therapy among those with HR-positive disease for the treatment of locally recurrent or metastatic disease, no greater than 1 month prior to enrollment Exclusion Criteria - Any medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to provide informed consent or comply with the treatment - Concurrent participation in a blinded clinical trial
Study is available at: All Saints Cancer Center
Racine, WI 53405
United States

Primary Contact:
Sandy Georgeson
Email: sgeorgeson@allsaintshealthcare.org
Phone: 262-687-5057

Secondary Contact:
Trial Information Support Line
Phone: 866-850-9521
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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