Study of Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Participants With Early/Metastatic Breast Cancer in Saudi Arabia
A Retrospective, Observational Molecular Epidemiology Study of HER2 Expression in Patients With Early / Metastatic Breast Cancer in Saudi Arabia
1 other identifier
observational
351
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2016
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 21, 2016
CompletedFirst Submitted
Initial submission to the registry
November 2, 2016
CompletedFirst Posted
Study publicly available on registry
November 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 17, 2019
CompletedSeptember 20, 2019
September 1, 2019
2.9 years
November 2, 2016
September 18, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Positive HER2 Test Result
From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
Secondary Outcomes (9)
Percentage of Participants With Estrogen Receptor/Progesterone Receptor Positive Breast Cancer
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
From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
Kaplan-Meier Estimate of Overall Survival (OS)
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)
From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
Percentage of Participants With Complete Response as Assessed Using RECIST
From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
- +4 more secondary outcomes
Study Arms (1)
Participants With Breast Cancer
This study will retrospectively collect data from participants with breast cancer in Saudi Arabia.
Eligibility Criteria
Participants With Early/Metastatic Breast Cancer in Saudi Arabia
You may qualify if:
- 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
You may not qualify if:
- \- Inconclusive, equivocal or unavailable result of HER2/neu overexpression by IHC and FISH
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
King Fahad Specialist Hospital; Oncology
Dammam, 31444, Saudi Arabia
King Faisal Specialist Hospital & Research Centre
Jeddah, 21499, Saudi Arabia
National Guard King Abdulaziz Medical City; Oncology
Riyadh, 11426, Saudi Arabia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2016
First Posted
November 3, 2016
Study Start
October 21, 2016
Primary Completion
September 17, 2019
Study Completion
September 17, 2019
Last Updated
September 20, 2019
Record last verified: 2019-09