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

Withdrawn

• Conditions: Breast Cancer, HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer
• Interventions: Other: No intervention

• Registration Number: NCT02616224
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-19
• Study First Submitted QC: 2015-11-25
• Study First Posted: 2015-11-26
• Study Start: 2016-09
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-23
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Read More

Exclusion Criteria

There are no exclusion criteria for entry into this study.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with unresectable LA/mBC	No intervention	-

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS) For Each Anti-Cancer Treatment Regimen	Up to approximately 8 years

Secondary Outcome Measures

Name	Time	Method
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