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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Tumor response will be evaluated by the Investigator according to site-specific medical practice. Study protocol does not specify any particular method of assessment. |
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Inclusion Criteria:
Exclusion Criteria:
- There are no exclusion criteria for entry into this study
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Participants with HER2-positive unresectable LABC or mBC
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kent & Canterbury Hospital | Canterbury | CT1 3NG | United Kingdom | |||
| Chesterfield Royal Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40358647 | Derived | 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. |
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| 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) | 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 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) |
| Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Baseline up to approximately 8 years |
| Percentage of Participants by Reasons for Treatment Modification | Baseline up to approximately 8 years |
| Percentage of Participants Receiving Each Treatment Regimen Categorized by Participant Characteristics | Baseline up to approximately 8 years |
| Number of Treatment Regimens Received | Baseline up to approximately 8 years |
| Euro Quality of Life 5-Dimension Questionnaire (EQ-5D) Score | Baseline up to approximately 8 years (assessed every 3 months) |
| Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score | Baseline up to approximately 8 years (assessed every 3 months) |
| Work Productivity and Activity Impairment (WPAI) Questionnaire Score | Baseline up to approximately 8 years (assessed every 3 months) |
| Percentage of Participants with Different Anti-Cancer Treatment Regimens by Country | Baseline up to approximately 8 years |
| Percentage of Participants with History of Breast Cancer by Different Anti-Cancer Treatment Regimens | Baseline up to approximately 8 years |
| Percentage of Participants with CNS-only Disease Progression | From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years) |
| Percentage of Participants with Oligometastatic Disease Categorized by Different Anti-Cancer Treatment Regimens | Baseline up to approximately 8 years |
| 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 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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