A Study To Observe Treatment Patterns and Outcomes in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer

Hoffmann-La Roche0 sitesSeptember 2016

ConditionsBreast Cancer, HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer, HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer
Sponsor: Hoffmann-La Roche
Primary Endpoint: Progression-Free Survival (PFS) For Each Anti-Cancer Treatment Regimen
Status: Withdrawn
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This observational disease registry is a prospective, national, non-interventional study designed to enroll participants who have received an initial diagnosis of unresectable, locally advanced (LA) or metastatic breast cancer (mBC), up to 6 months prior to registry enrolment. These participants will be prospectively followed for at least 5 years after study enrolment to evaluate their anti-cancer treatments. Data on participants' previous anti-cancer treatments for breast cancer will be collected retrospectively at study entry.

Registry

clinicaltrials.gov

Start Date

September 2016

End Date

December 2025

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Initially diagnosed with HER2-positive unresectable LA/mBC no more than 6 months prior to enrolment, although they can have received anti-cancer treatment during that time

Exclusion Criteria

•There are no exclusion criteria for entry into this study.

Outcomes

Primary Outcomes

Progression-Free Survival (PFS) For Each Anti-Cancer Treatment Regimen

Time Frame: Up to approximately 8 years

Secondary Outcomes

Overall Survival (OS)(Up to approximately 8 years)
Objective Response Rate (ORR) For Each Anti-Cancer Treatment Regimen(Up to approximately 8 years)
Number and Percentage of Participants Receiving Each Unique Treatment Regimen Overall and as First-Line Therapy Versus Second-Line Therapy Versus Subsequent-Line Therapy(Up to approximately 8 years)