Breast Cancer
Conditions
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.
Interventions
None listed
Sponsors
Genentech, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Distribution of patients receiving unique treatment regimen/sequence of treatment regimens | Up to 8 years |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS) | Up to 8 years |
| Post-progression survival (PPS) | Up to 8 years |
| Time-to-treatment failure (TTF) | Up to 8 years |
| Progression-free survival (PFS) | Up to 8 years |
| Safety: Incidence of adverse events | Up to 8 years |
| Patient-reported outcome assessment (PRO) | Up to 8 years |
| Response rate (RR) | Up to 8 years |
Countries
United States
Outcome results
None listed