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
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: 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 August 21, 2014