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Completed

NCT Number: NCT02393924

Human Epidermal Growth Factor Receptor 2 (HER2) Positive Unresectable Locally Advanced or Metastatic Breast Cancer Disease Registry Study

This disease registry is a prospective, multicenter non-interventional study designed to observe the different anticancer treatment regimens and their sequencing throughout the course of the disease in participants with unresectable locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) and to describe the clinical outcome for each treatment regimen measured as progression-free survival.

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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

Kent & Canterbury Hospital, Canterbury, United Kingdom

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 LABC or mBC no more than 6 months prior to enrollment, although they can have received anti-cancer treatment during that time
  • Able and willing to provide written informed consent and to comply with the study protocol

Exclusion criteria

  • There are no exclusion criteria for entry into this study

Treatment and study plan

No intervention

Other

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

    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-specific medical practice. Study protocol does not specify any particular method of assessment.

Secondary outcomes

  1. 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)

  2. Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR)

    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-specific medical practice. Study protocol does not specify any particular method of assessment.

  3. 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-specific medical practice. Study protocol does not specify any particular method of assessment.

  4. Time to Treatment Failure

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

  5. Percentage of Participants With Central Nervous System (CNS) as First Site of Progression

    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)

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

    Time frame: Baseline up to approximately 8 years

  7. Percentage of Participants by Reasons for Treatment Modification

    Time frame: Baseline up to approximately 8 years

  8. Percentage of Participants Receiving Each Treatment Regimen Categorized by Participant Characteristics

    Time frame: Baseline up to approximately 8 years

  9. Number of Treatment Regimens Received

    Time frame: Baseline up to approximately 8 years

  10. Euro Quality of Life 5-Dimension Questionnaire (EQ-5D) Score

    Time frame: Baseline up to approximately 8 years (assessed every 3 months)

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

    Time frame: Baseline up to approximately 8 years (assessed every 3 months)

  12. Work Productivity and Activity Impairment (WPAI) Questionnaire Score

    Time frame: Baseline up to approximately 8 years (assessed every 3 months)

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

    Time frame: Baseline up to approximately 8 years

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

    Time frame: Baseline up to approximately 8 years

  15. Percentage of Participants with CNS-only Disease Progression

    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)

  16. Percentage of Participants with Oligometastatic Disease Categorized by Different Anti-Cancer Treatment Regimens

    Time frame: Baseline up to approximately 8 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Acronym: ESTHER

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Mar 20, 2015
Registry last updated
Feb 21, 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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