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Completed

NCT Number: NCT02913456

A European Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced (LA) or Metastatic Breast Cancer (mBC) (SAMANTHA)

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 LA/mBC. Diagnosis of unresectable LA or mBC can be up to 6 months old prior to registry enrollment.

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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

LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie, Graz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Initially diagnosed with HER2-positive unresectable LA/mBC no more than 6 months prior to enrollment, although they can have received anti-cancer treatment during that time

Exclusion criteria

  • Not applicable

Treatment and study plan

Primary outcomes

  1. Progression-free Survival per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice

    Time frame: Baseline up to 8 years

  2. Percentage of Participants by Different Anti-cancer Treatment Regimens and Treatment Sequences

    Time frame: Baseline up to 8 years

Secondary outcomes

  1. Overall Survival

    Time frame: Baseline up to 8 years

  2. Duration of Response per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice

    Time frame: Baseline up to 8 years

  3. Percentage of Participants with Best Overall Response of Complete Response (CR) or Partial Response (PR) per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice

    Time frame: Baseline up to 8 years

  4. Total Number of Treatment Regimens Received by Participants

    Time frame: Baseline up to 8 years

  5. Percentage of Participants with Adverse Events (AEs), Serious AEs, and Protocol-defined AEs of Special Interest

    Time frame: Baseline up to 8 years

  6. Percentage of Participants with HER2 Re-testing of Metastases

    Time frame: Baseline up to 8 years

  7. Percentage of Participants with Change in HER2 Status

    Time frame: Baseline up to 8 years

  8. Percentage of Participants by Type of HER2 Testing (Immunohistochemistry and/or Fluorescence In situ Hybridization [FISH])

    Time frame: Baseline up to 8 years

  9. Percentage of Participants with Different Anti-Cancer Treatment Regimens by Country

    Time frame: Baseline up to 8 years

  10. Percentage of Participants with History of Breast Cancer by Different Anti-Cancer Treatment Regimens

    Time frame: Baseline up to 8 years

  11. EuroQol 5-Dimensions Questionnaire (EQ-5D) Score

    Time frame: Baseline up to 8 years

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

    Time frame: Baseline up to 8 years

  13. Total Healthcare Cost

    Time frame: Baseline up to 8 years

  14. Cost of Treating Associated AEs

    Time frame: Baseline up to 8 years

  15. Resource Utilization: Percentage of Participants with Breast Cancer Associated Procedures

    Time frame: Baseline up to 8 years

  16. Resource Utilization: Percentage of Participants with Hospitalization

    Time frame: Baseline up to 8 years

  17. Resource Utilization: Percentage of Participants with Emergency Room Attendances and Outpatient Visits

    Time frame: Baseline up to 8 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A European 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
2024
Study completion
2024
First posted
Sep 23, 2016
Registry last updated
Mar 6, 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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