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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02954471

Enrollment

351

Registered

2016-11-03

Start date

2016-10-21

Completion date

2019-09-17

Last updated

2019-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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)
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)
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 Partial Response as Assessed Using RECIST	From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)

Countries

Saudi Arabia

Outcome results