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

Completed

• Conditions: Breast Cancer

• Registration Number: NCT02954471
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-10-21
• Study First Submitted: 2016-11-02
• Study First Submitted QC: 2016-11-02
• Study First Posted: 2016-11-03
• Status Verified: 2019-09
• Primary Completion: 2019-09-17
• Study Completion: 2019-09-17
• Last Update Submitted: 2019-09-18
• Last Update Posted: 2019-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 351

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Positive HER2 Test Result	From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)

Secondary Outcome Measures

Name	Time	Method
Kaplan-Meier Estimate of Overall Survival (OS)	From January 2007 to December 2015 (Up to 9 years; assessed retrospectively)
Percentage of Participants with Stable Disease as Assessed Using RECIST	From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
Percentage of Participants With Adverse Events	From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
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 With Progressive Disease as Assessed Using RECIST	From January 2007 to December 2013 (Up to 7 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)
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)
Percentage of Participants With Partial Response as Assessed Using RECIST	From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)

Trial Locations

Locations (3)

King Faisal Specialist Hospital & Research Centre; 🇸🇦 Jeddah, Saudi Arabia

King Fahad Specialist Hospital; Oncology; 🇸🇦 Dammam, Saudi Arabia

National Guard King Abdulaziz Medical City; Oncology; 🇸🇦 Riyadh, Saudi Arabia