ESTHER: Human Epidermal Growth Factor Receptor 2 (HER2) Positive Unresectable Locally Advanced or Metastatic Breast Cancer Disease Registry Study
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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. |
Other: No intervention
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Outcome Measures
Primary Outcome Measures
- 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 [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 Outcome Measures
- 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)]
Tumor response will be evaluated by the Investigator according to site-specific medical practice. Study protocol does not specify any particular method of assessment.
- Duration of Response (DoR) [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.
- 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)]
- Healthcare Resource Utilization - Percentage of Participants Who Are Hospitalized [Baseline up to approximately 8 years (assessed every 3 months)]
- Healthcare Resource Utilization - Percentage of Participants With Emergency Room Visit [Baseline up to approximately 8 years (assessed every 3 months)]
- Healthcare Resource Utilization - Percentage of Participants With Outpatient Visit [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]
Eligibility Criteria
Criteria
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
Exclusion Criteria:
- There are no exclusion criteria for entry into this study
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Kent & Canterbury Hospital | Canterbury | United Kingdom | CT1 3NG | |
2 | Chesterfield Royal Hospital | Chesterfield | United Kingdom | S44 5BL | |
3 | Royal Cornwall Hospital; Dept of Clinical Oncology | Cornwall | United Kingdom | TR1 3LQ | |
4 | Castle Hill Hospital; The Queens Centre for Oncology and Haematology | Cottingham | United Kingdom | HU16 5JG | |
5 | Hairmyres Hospital; Oncology Dept | East Kilbride | United Kingdom | G75 8RG | |
6 | Queen Elizabeth Hospital | Gateshead | United Kingdom | NE9 6SX | |
7 | Raigmore Hospital | Inverness | United Kingdom | IV2 3UV | |
8 | Forth Valley Royal Hospital ; Oncology Department | Larbert | United Kingdom | FK5 4QE | |
9 | Queen Elizabeth Hospital | London | United Kingdom | SE18 4QH | |
10 | Royal Marsden Hospital; Dept of Med-Onc | London | United Kingdom | SW3 6JJ | |
11 | Charing Cross Hospital; Medical Oncology. | London | United Kingdom | W6 8RF | |
12 | Macclesfield District General Hospital | Macclesfield | United Kingdom | SK10 3BL | |
13 | Maidstone Hospital; Kent Oncology Centre | Maidstone | United Kingdom | ME16 9QQ | |
14 | Christie Hospital Nhs Trust; Medical Oncology | Manchester | United Kingdom | M2O 4BX | |
15 | James Cook University Hospital; Oncology and Radiology | Middlesbrough | United Kingdom | TS4 3BW | |
16 | Northampton General Hospital NHS Trust;Oncology Unit | Northampton | United Kingdom | NN1 5BD | |
17 | Mount Vernon & Watford Trust Hospital; Dept. of Clinical Oncology | Northwood | United Kingdom | HA6 2RN | |
18 | Norfolk & Norwich University Hospital; Oncology Department | Norwich | United Kingdom | NR4 7UY | |
19 | Nottingham City Hospital; Oncology | Nottingham | United Kingdom | NG5 1PB | |
20 | Derriford Hospital; Plymouth Oncology Centre | Plymouth | United Kingdom | PL6 8DH | |
21 | Royal Preston Hosp; Rosemere Cancer Ctr | Preston | United Kingdom | PR2 9HT | |
22 | North Wales Cancer Treatment Centre, Glan Clwyd Hospital | Rhyl | United Kingdom | LL18 5UJ | |
23 | Scarborough General Hospital | Scarborough | United Kingdom | YO12 6QL | |
24 | Royal Shrewsbury Hospitals Nhs Trust; Oncology | Shrewsbury | United Kingdom | SY3 8XQ | |
25 | Royal Marsden Hospital; Dept of Medical Oncology | Sutton | United Kingdom | SM2 5PT | |
26 | Singleton Hospital; Pharmacy | Swansea | United Kingdom | SA2 8QA | |
27 | Great Western Hospital, Swindon Cancer Research Unit; Osprey Unit Level 3 | Swindon | United Kingdom | SN3 6BB | |
28 | Pinderfields Hospital; Clinical Research Team, Rowan House | Wakefield | United Kingdom | WF1 4DG | |
29 | Yeovil District Hospital; Macmillan Unit | Yeovil | United Kingdom | BA21 4AT | |
30 | Airedale General Hospital; Oncology | York | United Kingdom | BD20 6TD |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ML29659