NCT02954471 - Study of Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Participants With Early/Metastatic Breast Cancer in Saudi Arabia | Crick | Crick

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

N/ACompletedNCT02954471

Hoffmann-La Roche351 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

351

Conditions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

King Fahad Specialist Hospital; Oncology

Dammam, Saudi Arabia

King Faisal Specialist Hospital & Research Centre

Jeddah, Saudi Arabia

National Guard King Abdulaziz Medical City; Oncology

Riyadh, Saudi Arabia

Outcomes

Primary Outcomes

Percentage of Participants With Positive HER2 Test Result

Time frame: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)

Secondary Outcomes

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)

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)

Kaplan-Meier Estimate of Overall Survival (OS)

Time frame: 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)

Percentage of Participants With Complete Response as Assessed Using RECIST

Time frame: 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)

Percentage of Participants With Progressive Disease as Assessed Using RECIST

Time frame: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)

Percentage of Participants with Stable Disease as Assessed Using RECIST

Data from ClinicalTrials.gov

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