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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02954471
• Other study ID #: ML29903
• Status: Completed
• Start date: October 21, 2016
• Est. completion date: September 17, 2019

Study information

• Verified date: September 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: September 17, 2019
• Est. primary completion date: September 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Saudi Arabia	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

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Positive HER2 Test Result		From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
Secondary	Percentage of Participants With Estrogen Receptor/Progesterone Receptor Positive Breast Cancer		From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
Secondary	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)
Secondary	Kaplan-Meier Estimate of Overall Survival (OS)		From January 2007 to December 2015 (Up to 9 years; assessed retrospectively)
Secondary	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)
Secondary	Percentage of Participants With Complete Response as Assessed Using RECIST		From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
Secondary	Percentage of Participants With Partial Response as Assessed Using RECIST		From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
Secondary	Percentage of Participants With Progressive Disease as Assessed Using RECIST		From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
Secondary	Percentage of Participants with Stable Disease as Assessed Using RECIST		From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
Secondary	Percentage of Participants With Adverse Events		From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)