This trial is active, not recruiting.

Condition breast cancer
Sponsor Genentech, Inc.
Start date June 2012
End date June 2020
Trial size 1017 participants
Trial identifier NCT01615068, ML28257


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Distribution of patients receiving unique treatment regimen/sequence of treatment regimens
time frame: Up to 8 years

Secondary Outcomes

Progression-free survival (PFS)
time frame: Up to 8 years
Overall survival (OS)
time frame: Up to 8 years
Post-progression survival (PPS)
time frame: Up to 8 years
Time-to-treatment failure (TTF)
time frame: Up to 8 years
Response rate (RR)
time frame: Up to 8 years
Safety: Incidence of adverse events
time frame: Up to 8 years
Patient-reported outcome assessment (PRO)
time frame: Up to 8 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title An Observational Cohort Study Of Treatment Patterns And Outcomes In Patients With HER2 Positive (Her2+) Metastatic Breast Cancer (SystHERs Registry (Systematic Therapies for HER2+ Metastatic Breast Cancer Study)).
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Genentech, Inc..