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NCT Number: NCT02954471

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

King Fahad Specialist Hospital; Oncology, Dammam, Saudi Arabia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Percentage of Participants With Positive HER2 Test Result

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

Secondary outcomes

  1. 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)

  2. 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)

  3. Kaplan-Meier Estimate of Overall Survival (OS)

    Time frame: From January 2007 to December 2015 (Up to 9 years; assessed retrospectively)

  4. 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)

  5. Percentage of Participants With Complete Response as Assessed Using RECIST

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

  6. Percentage of Participants With Partial Response as Assessed Using RECIST

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

  7. Percentage of Participants With Progressive Disease as Assessed Using RECIST

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

  8. Percentage of Participants with Stable Disease as Assessed Using RECIST

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

  9. Percentage of Participants With Adverse Events

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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 3, 2016
Registry last updated
Sep 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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