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

This study is ongoing, but not recruiting participants.

First Received on July 30, 2008. Last Updated on February 6, 2012 History of Changes

Sponsor:	Genentech
Information provided by (Responsible Party):	Genentech
ClinicalTrials.gov Identifier:	NCT00726661

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.

Condition	Phase
Breast Cancer	Phase IV

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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by Genentech:

Biospecimen Retention: Samples With DNA

Whole blood

Enrollment:	29
Study Start Date:	June 2008

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-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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726661

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Amy Sing, 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:	February 6, 2012
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 February 09, 2012