Clinical trial NCT02954471: Study of Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Participants With Early/Metastatic Breast Cancer in Saudi Arabia
Official title: A Retrospective, Observational Molecular Epidemiology Study of HER2 Expression in Patients With Early / Metastatic Breast Cancer in Saudi Arabia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-11-03
Enrollment: 351
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants With Early/Metastatic Breast Cancer in Saudi Arabia

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Positive HER2 Test Result
timeFrame: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
Secondary outcomes:
measure: Percentage of Participants With Estrogen Receptor/Progesterone Receptor Positive Breast Cancer
timeFrame: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
measure: Percentage of Participants by Type of First-line and Subsequent Treatment Regimens Used
timeFrame: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
measure: Kaplan-Meier Estimate of Overall Survival (OS)
timeFrame: From January 2007 to December 2015 (Up to 9 years; assessed retrospectively)
measure: Kaplan-Meier Estimates of Progression-free Survival (PFS) as Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
measure: Percentage of Participants With Complete Response as Assessed Using RECIST
timeFrame: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
measure: Percentage of Participants With Partial Response as Assessed Using RECIST
timeFrame: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
measure: Percentage of Participants With Progressive Disease as Assessed Using RECIST
timeFrame: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
measure: Percentage of Participants with Stable Disease as Assessed Using RECIST
timeFrame: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
measure: Percentage of Participants With Adverse Events
timeFrame: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
Other outcomes:
Locations:
city: Dammam
country: Saudi Arabia
facility: King Fahad Specialist Hospital; Oncology
city: Jeddah
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Centre
city: Riyadh
country: Saudi Arabia
facility: National Guard King Abdulaziz Medical City; Oncology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: