An Observational Study in Patients With HER2 Positive Metastatic Breast Cancer (SystHERs Registry)
- Conditions
- Breast Cancer
- Registration Number
- NCT01615068
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
This multi-center, prospective observational study will evaluate the treatment patterns, and the safety in patients with HER2-positive (HER2+) metastatic breast cancer (MBC). Eligible patients will have an initial metastatic breast cancer diagnosis that has not been previously treated with systemic therapy; patients may be enrolled up to 6 months after the diagnosis. Data will be collected for up to 8 years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1007
- Adult patients, >/=18 years of age
- Initial diagnosis of HER2+ MBC, as diagnosed by the treating physician, no more than 6 months prior to study enrollment
- Availability of cancer-specific historical data points in the patient's medical records
- Any inability to provide informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Distribution of patients receiving unique treatment regimen/sequence of treatment regimens Up to 8 years
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) Up to 8 years Time-to-treatment failure (TTF) Up to 8 years Post-progression survival (PPS) Up to 8 years Patient-reported outcome assessment (PRO) Up to 8 years Overall survival (OS) Up to 8 years Response rate (RR) Up to 8 years Safety: Incidence of adverse events Up to 8 years
Trial Locations
- Locations (142)
St. Vincent'S Hospital; Birmingham Hematology Oncology Associates, Llc
🇺🇸Birmingham, Alabama, United States
University of South Alabama; Mitchell Cancer Institute
🇺🇸Mobile, Alabama, United States
Arizona Oncology Associates, PC - NAHOA
🇺🇸Sedona, Arizona, United States
Arizona Oncology
🇺🇸Tucson, Arizona, United States
Genesis Cancer Center
🇺🇸Hot Springs, Arkansas, United States
NEA Baptist Clinic
🇺🇸Jonesboro, Arkansas, United States
Hematology Oncology Services of Arkansas
🇺🇸Little Rock, Arkansas, United States
Highlands Oncology Group
🇺🇸Rogers, Arkansas, United States
East Valley Hem/Onc Med Group; Metropolitan Hem Onc.
🇺🇸Burbank, California, United States
South Bay Oncology Hematology Partners
🇺🇸Campbell, California, United States
Scroll for more (132 remaining)St. Vincent'S Hospital; Birmingham Hematology Oncology Associates, Llc🇺🇸Birmingham, Alabama, United States