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, Inc.
ClinicalTrials.gov Identifier:
NCT00726661
First received: July 30, 2008
Last updated: January 31, 2014
Last verified: January 2014

July 30, 2008
January 31, 2014
June 2008
March 2013   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00726661 on ClinicalTrials.gov Archive Site
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An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer (VIRGO)
An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

Whole blood and tissue

Non-Probability Sample

Primary care clinic

Breast Cancer
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  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1287
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00726661
AVF4349n
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Genentech, Inc.
Genentech, Inc.
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Study Director: Darshan Dalal, M.D. Genentech, Inc.
Genentech, Inc.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP