Human Epidermal Growth Factor Receptor 2 (HER2) Positive Unresectable Locally Advanced or Metastatic Breast Cancer Disease Registry Study
ESTHER
UK - A Disease Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
1 other identifier
observational
311
1 country
30
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2015
Longer than P75 for all trials
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 23, 2015
CompletedFirst Submitted
Initial submission to the registry
March 12, 2015
CompletedFirst Posted
Study publicly available on registry
March 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 19, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 19, 2023
CompletedFebruary 21, 2024
February 1, 2024
8.2 years
March 12, 2015
February 20, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
Percentage of Participants Receiving Each Unique Treatment Regimen Overall
Baseline up to approximately 8 years
Percentage of Participants Receiving Each Unique Treatment Regimen as First-Line Versus Subsequent-Line Therapy
Baseline up to approximately 8 years
Percentage of Participants Receiving Each Unique Treatment Regimen Sequence
Baseline up to approximately 8 years
Progression-Free Survival
Tumor response will be evaluated by the Investigator according to site-specific medical practice. Study protocol does not specify any particular method of assessment.
From start date of anti-cancer treatment regimen to the date of either disease progression or death (up to approximately 8 years)
Secondary Outcomes (16)
Overall Survival (OS)
From the date of initiation of treatment to the date of death from any cause (up to approximately 8 years)
Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR)
From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years)
Duration of Response (DoR)
From date of first response (CR or PR) to the date of disease progression (up to approximately 8 years)
Time to Treatment Failure
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)
Percentage of Participants With Central Nervous System (CNS) as First Site of Progression
From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years)
- +11 more secondary outcomes
Study Arms (1)
Participants With HER2-Positive Breast Cancer
Enrolled participants will receive treatment and clinical assessments for their HER2-positive unresectable LABC/mBC as determined by their treating physician, according to the standard of care and routine clinical practice at each site. Participants will be followed until death, withdrawal of consent or study termination, whichever occurs first. Study protocol does not specify any particular drug or treatment regimen.
Interventions
Eligibility Criteria
Participants with HER2-positive unresectable LABC or mBC
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Kent & Canterbury Hospital
Canterbury, CT1 3NG, United Kingdom
Chesterfield Royal Hospital
Chesterfield, S44 5BL, United Kingdom
Royal Cornwall Hospital; Dept of Clinical Oncology
Cornwall, TR1 3LQ, United Kingdom
Castle Hill Hospital; The Queens Centre for Oncology and Haematology
Cottingham, HU16 5JG, United Kingdom
Hairmyres Hospital; Oncology Dept
East Kilbride, G75 8RG, United Kingdom
Queen Elizabeth Hospital
Gateshead, NE9 6SX, United Kingdom
Raigmore Hospital
Inverness, IV2 3UV, United Kingdom
Forth Valley Royal Hospital ; Oncology Department
Larbert, FK5 4QE, United Kingdom
Queen Elizabeth Hospital
London, SE18 4QH, United Kingdom
Royal Marsden Hospital; Dept of Med-Onc
London, SW3 6JJ, United Kingdom
Charing Cross Hospital; Medical Oncology.
London, W6 8RF, United Kingdom
Macclesfield District General Hospital
Macclesfield, SK10 3BL, United Kingdom
Maidstone Hospital; Kent Oncology Centre
Maidstone, ME16 9QQ, United Kingdom
Christie Hospital Nhs Trust; Medical Oncology
Manchester, M2O 4BX, United Kingdom
James Cook University Hospital; Oncology and Radiology
Middlesbrough, TS4 3BW, United Kingdom
Northampton General Hospital NHS Trust;Oncology Unit
Northampton, NN1 5BD, United Kingdom
Mount Vernon & Watford Trust Hospital; Dept. of Clinical Oncology
Northwood, HA6 2RN, United Kingdom
Norfolk & Norwich University Hospital; Oncology Department
Norwich, NR4 7UY, United Kingdom
Nottingham City Hospital; Oncology
Nottingham, NG5 1PB, United Kingdom
Derriford Hospital; Plymouth Oncology Centre
Plymouth, PL6 8DH, United Kingdom
Royal Preston Hosp; Rosemere Cancer Ctr
Preston, PR2 9HT, United Kingdom
North Wales Cancer Treatment Centre, Glan Clwyd Hospital
Rhyl, LL18 5UJ, United Kingdom
Scarborough General Hospital
Scarborough, YO12 6QL, United Kingdom
Royal Shrewsbury Hospitals Nhs Trust; Oncology
Shrewsbury, SY3 8XQ, United Kingdom
Royal Marsden Hospital; Dept of Medical Oncology
Sutton, SM2 5PT, United Kingdom
Singleton Hospital; Pharmacy
Swansea, SA2 8QA, United Kingdom
Great Western Hospital, Swindon Cancer Research Unit; Osprey Unit Level 3
Swindon, SN3 6BB, United Kingdom
Pinderfields Hospital; Clinical Research Team, Rowan House
Wakefield, WF1 4DG, United Kingdom
Yeovil District Hospital; Macmillan Unit
Yeovil, BA21 4AT, United Kingdom
Airedale General Hospital; Oncology
York, BD20 6TD, United Kingdom
Related Publications (1)
Ring A, Sutherland S, Harper-Wynne C, Owen J, Sanglier T, Velikova G. A disease registry study to prospectively observe treatment patterns and outcomes in patients with HER2-positive unresectable LA/MBC: final results of the ESTHER study. Breast Cancer Res Treat. 2025 Jul;212(1):113-121. doi: 10.1007/s10549-025-07708-4. Epub 2025 May 13.
PMID: 40358647DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 8 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2015
First Posted
March 20, 2015
Study Start
February 23, 2015
Primary Completion
April 19, 2023
Study Completion
April 19, 2023
Last Updated
February 21, 2024
Record last verified: 2024-02