Overview

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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

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

Secondary Outcomes

Measure
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 November 2016.
Information provided to ClinicalTrials.gov by Genentech, Inc..