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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00726661
First received: July 30, 2008
Last updated: January 31, 2014
Last verified: January 2014
  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-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.


Condition Phase
Breast Cancer
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer

Resource links provided by NLM:


Further study details as provided by Genentech:

Biospecimen Retention:   Samples With DNA

Whole blood and tissue


Enrollment: 1287
Study Start Date: June 2008
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
A
Patients with HER2-normal disease receiving their first cytotoxic chemotherapy and/or targeted therapy
B
Patients with HR-positive tumors receiving their first HT for advanced disease

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

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-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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00726661

Sponsors and Collaborators
Genentech
Investigators
Study Director: Darshan Dalal, M.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00726661     History of Changes
Other Study ID Numbers: AVF4349n
Study First Received: July 30, 2008
Last Updated: January 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Genentech:
MBC
Locally Recurrent Breast Cancer
Avastin

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

ClinicalTrials.gov processed this record on April 21, 2014