An Observational Study Evaluating the Productivity and Health-Related Quality of Life of People With HER2 Positive Breast Cancer

  • Cancer
  • Breast Cancer
  • Breast Cancer HER-2 Positive
  • Breast Neoplasms
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Completed

This study runs in
Country
  • United Kingdom
Study Identifier:

NCT03099200 ML30098

      Show study locations

      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Study Summary

      The purpose of this study is to compare productivity (in terms of work or daily activity) and generic and disease-specific health-related quality of life of participants with HER2 positive early breast cancer currently receiving adjuvant treatment (with chemotherapy and/or targeted HER2 therapy), with participants who have completed adjuvant parenteral therapy, and participants with HER2 positive metastatic breast cancer.

      Hoffmann-La Roche Sponsor
      N/A Phase
      NCT03099200, ML30098 Study Identifier
      No Intervention Treatments
      Breast Neoplasms Condition
      Official Title

      UK HER2 Positive Breast Cancer Productivity & Utility Non-Interventional Study (PURPOSE)

      Eligibility Criteria

      All Gender
      ≥ 18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Diagnosed with early stage or metastatic (Stage IV) HER2-positive breast cancer (confirmed by the study site physician). [HER2-positive is defined as ImmunoHistoChemistry (IHC3+) and/or in situ hybridization (ISH) ≥2.0]
      • Able to provide written, informed consent.
      • Early Stage Breast Cancer (eBC) patients must have received at least 1 cycle of adjuvant anti-cancer therapy following surgery; metastatic breast cancer (mBC) patients must have received at least 1 cycle of treatment for their metastatic disease.
      Exclusion Criteria
      • Unwilling or unable to consent.
      • Unable to complete written quality of life questionnaires
      • Partcipants with Eastern Cooperative Oncology Group (ECOG) Performance Status ≥3

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