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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02393924
Collaborator
(none)
313
30
97
10.4
0.1

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
  • Other: No intervention

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
313 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official 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
Actual Study Start Date :
Feb 23, 2015
Anticipated Primary Completion Date :
Mar 24, 2023
Anticipated Study Completion Date :
Mar 24, 2023

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Percentage of Participants Receiving Each Unique Treatment Regimen Overall [Baseline up to approximately 8 years]

  2. Percentage of Participants Receiving Each Unique Treatment Regimen as First-Line Versus Subsequent-Line Therapy [Baseline up to approximately 8 years]

  3. Percentage of Participants Receiving Each Unique Treatment Regimen Sequence [Baseline up to approximately 8 years]

  4. 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

  1. Overall Survival (OS) [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) [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) [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 [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 [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) [Baseline up to approximately 8 years]

  7. Percentage of Participants by Reasons for Treatment Modification [Baseline up to approximately 8 years]

  8. Percentage of Participants Receiving Each Treatment Regimen Categorized by Participant Characteristics [Baseline up to approximately 8 years]

  9. Number of Treatment Regimens Received [Baseline up to approximately 8 years]

  10. Euro Quality of Life 5-Dimension Questionnaire (EQ-5D) Score [Baseline up to approximately 8 years (assessed every 3 months)]

  11. Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score [Baseline up to approximately 8 years (assessed every 3 months)]

  12. Work Productivity and Activity Impairment (WPAI) Questionnaire Score [Baseline up to approximately 8 years (assessed every 3 months)]

  13. Healthcare Resource Utilization - Percentage of Participants Who Are Hospitalized [Baseline up to approximately 8 years (assessed every 3 months)]

  14. Healthcare Resource Utilization - Percentage of Participants With Emergency Room Visit [Baseline up to approximately 8 years (assessed every 3 months)]

  15. Healthcare Resource Utilization - Percentage of Participants With Outpatient Visit [Baseline up to approximately 8 years (assessed every 3 months)]

  16. Percentage of Participants with Different Anti-Cancer Treatment Regimens by Country [Baseline up to approximately 8 years]

  17. Percentage of Participants with History of Breast Cancer by Different Anti-Cancer Treatment Regimens [Baseline up to approximately 8 years]

  18. 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)]

  19. Percentage of Participants with Oligometastatic Disease Categorized by Different Anti-Cancer Treatment Regimens [Baseline up to approximately 8 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
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.
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02393924
Other Study ID Numbers:
  • ML29659
First Posted:
Mar 20, 2015
Last Update Posted:
Jun 28, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 28, 2022