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Completed

NCT Number: NCT02595762

A Study of Treatment Patterns and Outcomes in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced or Metastatic Breast Cancer

This disease registry is a prospective, multicenter non-interventional study designed to observe anti-cancer treatment regimens and clinical outcomes in participants with HER2-positive unresectable locally advanced breast cancer (LABC) or metastatic breast cancer (MBC).

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Locally Advanced Breast Cancer 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

Bank of Cyprus Oncology Center, Nicosia, Cyprus

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of HER2-positive unresectable LABC or MBC within 6 months prior to enrollment

Exclusion criteria

  • None specified

Treatment and study plan

Primary outcomes

  1. Percentage of Participants Receiving Each Unique Treatment Regimen Overall

    Time frame: Baseline up to approximately 8 years

  2. Percentage of Participants Receiving Each Unique Treatment Regimen as First-Line Versus Subsequent-Line Therapy

    Time frame: Baseline up to approximately 8 years

  3. Percentage of Participants Receiving Each Unique Treatment Regimen Sequence

    Time frame: Baseline up to approximately 8 years

  4. Progression-Free Survival (PFS)

    Time frame: From start date of anti-cancer treatment regimen to the date of either disease progression or death (up to approximately 8 years)

    Tumor response will be evaluated by the Investigator according to site-/country-specific medical practice. Study protocol does not specify any particular method of assessment.

Secondary outcomes

  1. Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)

    Time frame: Baseline up to approximately 8 years

  2. Percentage of Participants Receiving Each Treatment Regimen, by Participant Characteristics

    Time frame: Baseline up to approximately 8 years

  3. Percentage of Participants Receiving Each Treatment Regimen, by Country/Region

    Time frame: Baseline up to approximately 8 years

  4. Overall Survival (OS)

    Time frame: From the date of initiation of treatment to the date of death from any cause (up to approximately 8 years)

  5. Number of Treatment Regimens Received

    Time frame: Baseline up to approximately 8 years

  6. Percentage of Participants With Complete Response (CR) or Partial Response (PR) - Objective Response Rate (ORR)

    Time frame: From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years)

    Tumor response will be evaluated by the Investigator according to site-/country-specific medical practice. Study protocol does not specify any particular method of assessment.

  7. Duration of Response (DOR)

    Time frame: From date of first response (CR or PR) to the date of disease progression (up to approximately 8 years)

    Tumor response will be evaluated by the Investigator according to site-/country-specific medical practice. Study protocol does not specify any particular method of assessment.

  8. Percentage of Participants by Reasons for Treatment Modification

    Time frame: Baseline up to approximately 8 years

  9. EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Score

    Time frame: Baseline up to approximately 8 years

  10. Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score

    Time frame: Baseline up to approximately 8 years

  11. Work Productivity and Activity Impairment-General Health (WPAI-GH) Questionnaire Score

    Time frame: Baseline up to approximately 8 years

  12. Percentage of Participants With HER2 Retesting

    Time frame: Baseline up to approximately 8 years

  13. Percentage of Participants With HER2 Overexpression, as Assessed Using In Situ Hybridization or Immunohistochemistry

    Time frame: Baseline up to approximately 8 years

  14. Healthcare Resource Utilization - Total Healthcare Cost

    Time frame: Baseline up to approximately 8 years

  15. Healthcare Resource Utilization - Percentage of Participants Who Are Hospitalized

    Time frame: Baseline up to approximately 8 years

  16. Healthcare Resource Utilization - Length of Hospitalization

    Time frame: Baseline up to approximately 8 years

  17. Healthcare Resource Utilization - Percentage of Participants With Emergency Room Visit

    Time frame: Baseline up to approximately 8 years

  18. Healthcare Resource Utilization - Percentage of Participants With Outpatient Visit

    Time frame: Baseline up to approximately 8 years

  19. Healthcare Resource Utilization - Cost of Disease Related Out-of-Pocket Healthcare Expenditures

    Time frame: Baseline up to approximately 8 years

  20. Healthcare Resource Utilization - Indirect Disease Related Cost

    Time frame: Baseline up to approximately 8 years

  21. Healthcare Resource Utilization - Number of Working Hours Missed Among Informal Caregivers due to Disease-Related Caregiving Responsibilities

    Time frame: Baseline up to approximately 8 years

  22. Healthcare Resource Utilization - Percentage of Participants Receiving Monetary Social Benefits

    Time frame: Baseline up to approximately 8 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Disease Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Nov 3, 2015
Registry last updated
Aug 19, 2024

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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