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Withdrawn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
|
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
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.