An Observational Study in Patients With HER2 Positive Metastatic Breast Cancer (SystHERs Registry)

Genentech

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT01615068

ML28257

Details and patient eligibility

About

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.

Enrollment: 1,007 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Any inability to provide informed consent

Trial design

1,007 participants in 1 patient group

Cohort