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

February 22, 2017 updated by: Hoffmann-La Roche
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants who have an initial diagnosis of unresectable LA/mBC made up to 6 months prior to registry enrolment.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants with unresectable LA/mBC
Other: No intervention
No intervention was administered in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-Free Survival (PFS) For Each Anti-Cancer Treatment Regimen
Time Frame: Up to approximately 8 years
Up to approximately 8 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: Up to approximately 8 years
Up to approximately 8 years
Objective Response Rate (ORR) For Each Anti-Cancer Treatment Regimen
Time Frame: Up to approximately 8 years
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
Time Frame: Up to approximately 8 years
Up to approximately 8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2016

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

November 19, 2015

First Submitted That Met QC Criteria

November 25, 2015

First Posted (Estimate)

November 26, 2015

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML29019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer, HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer

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