Study of Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Participants With Early/Metastatic Breast Cancer in Saudi Arabia

September 18, 2019 updated by: Hoffmann-La Roche

A Retrospective, Observational Molecular Epidemiology Study of HER2 Expression in Patients With Early / Metastatic Breast Cancer in Saudi Arabia

This is a retrospective, multicenter study, consisting of chart review of Saudi Arabian participants diagnosed with breast cancer between 2007 and 2013 and with available human epidermal growth factor receptor 2 (HER2) testing. Data on survival will be collected through 2015.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

351

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Dammam, Saudi Arabia, 31444
        • King Fahad Specialist Hospital; Oncology
      • Jeddah, Saudi Arabia, 21499
        • King Faisal Specialist Hospital & Research Centre
      • Riyadh, Saudi Arabia, 11426
        • National Guard King Abdulaziz Medical City; Oncology

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 With Early/Metastatic Breast Cancer in Saudi Arabia

Description

Inclusion Criteria:

  • Initially diagnosed with breast cancer
  • Has a proven result of HER2 testing by immunohistochemistry (IHC), fluorescent in situ hybridization (FISH) or any other in situ hybridization (ISH) method
  • Alive or not alive

Exclusion Criteria:

- Inconclusive, equivocal or unavailable result of HER2/neu overexpression by IHC and FISH

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Participants With Breast Cancer
This study will retrospectively collect data from participants with breast cancer in Saudi Arabia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With Positive HER2 Test Result
Time Frame: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With Estrogen Receptor/Progesterone Receptor Positive Breast Cancer
Time Frame: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
Percentage of Participants by Type of First-line and Subsequent Treatment Regimens Used
Time Frame: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
Kaplan-Meier Estimate of Overall Survival (OS)
Time Frame: From January 2007 to December 2015 (Up to 9 years; assessed retrospectively)
From January 2007 to December 2015 (Up to 9 years; assessed retrospectively)
Kaplan-Meier Estimates of Progression-free Survival (PFS) as Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
Percentage of Participants With Complete Response as Assessed Using RECIST
Time Frame: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
Percentage of Participants With Partial Response as Assessed Using RECIST
Time Frame: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
Percentage of Participants With Progressive Disease as Assessed Using RECIST
Time Frame: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
Percentage of Participants with Stable Disease as Assessed Using RECIST
Time Frame: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
Percentage of Participants With Adverse Events
Time Frame: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)

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 (Actual)

October 21, 2016

Primary Completion (Actual)

September 17, 2019

Study Completion (Actual)

September 17, 2019

Study Registration Dates

First Submitted

November 2, 2016

First Submitted That Met QC Criteria

November 2, 2016

First Posted (Estimate)

November 3, 2016

Study Record Updates

Last Update Posted (Actual)

September 20, 2019

Last Update Submitted That Met QC Criteria

September 18, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML29903

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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