Clinical trial NCT00726661: An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer (VIRGO)
Official title: An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Metastatic Breast Cancer
Locally Recurrent Breast Cancer
Avastin
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2008-08-01
Enrollment: 1287
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer clinic

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Progression Free Survival
timeFrame: Approximately 4.5 years
Secondary outcomes:
measure: Overall Survival
timeFrame: Approximately 4.5 years
measure: Number of Participants With Tumor Response
timeFrame: Approximately 4.5 years
measure: Number of Hormone Receptor-positive Participants Who Initiated Cytotoxic Chemotherapy Following Discontinuation
timeFrame: Approximately 4.5 years
measure: Number of Participants With Any Adverse Events, Any Serious Adverse Events, Any AEs Leading to Early Treatment Discontinuation, and Adverse Events Leading to Hospitalization or Death
timeFrame: Approximately 4.5 years
measure: Number of Participants With Arterial Thromboembolic Events, Venous Thromboembolic Events, Left Ventricular Systolic Dysfunction, and Peripheral Neuropathy
timeFrame: Approximately 4.5 years
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: