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

Genentech

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT00726661

AVF4349n

Details and patient eligibility

About

This is a multicenter, prospective observational cohort study (OCS) designed to follow patients with locally recurrent or metastatic breast cancer in the United States. Two cohorts will be included:

• Patients with human epidermal growth factor receptor 2-negative (HER2-negative) disease receiving their first cytotoxic chemotherapy and/or targeted therapy (approximately 825 patients)
• Patients with hormone receptor-positive (HR-positive) disease receiving their first hormonal therapy 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.

Enrollment: 1,287 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

1,287 participants in 2 patient groups

Chemotherapy Cohort

Description:

Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).

Hormonal Therapy Cohort

Description:

Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).