An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer (VIRGO)

Breast Cancer Clinical Trial

— VIRGO  

Official title:

An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00726661
• Other study ID #: AVF4349n
• Status: Completed
• Phase: Phase 4
• First received: July 30, 2008
• Last updated: January 31, 2014
• Start date: June 2008
• Est. completion date: March 2013

Study information

• Verified date: January 2014
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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-negative disease receiving their first cytotoxic chemotherapy and/or targeted therapy (approximately 825 patients)

• Patients with HR-positive disease receiving their first HT for advanced disease (approximately 425 patients)

Patients who have received any chemotherapy for advanced disease more than 8 weeks prior to enrollment to this OCS will not be eligible. A total of approximately 1,250 patients will be enrolled. Approximately 150 study sites will be activated in order to achieve complete enrollment by December 2010.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1287
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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-negative disease or first hormone therapy among those with HR-positive disease for the treatment of locally recurrent or metastatic disease, within 8 weeks 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

• Any prior chemotherapy started more than 8 weeks prior to enrollment for the treatment of locally recurrent or for metastatic breast cancer

• Concurrent participation only in a blinded clinical trial

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.