An Observational Study Evaluating the Productivity and Health-Related Quality of Life of People With HER2 Positive Breast Cancer
NCT ID: NCT03099200
Last Updated: 2017-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
300 participants
OBSERVATIONAL
2016-12-12
2017-03-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Cohort 1
Participants with early breast cancer currently undergoing treatment (either chemotherapy and targeted HER2 therapy OR targeted HER2 therapy alone) will be observed.
No Intervention
Cohort 2
Participants with early breast cancer who have completed treatment and are in disease-free survival (i.e. no longer receiving loco-regional treatment, chemotherapy or targeted HER2 therapy; participants may still be receiving hormone therapy) will be observed.
No Intervention
Cohort 3
Participants receiving treatment for metastatic breast cancer will be observed.
No Intervention
Interventions
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No Intervention
Eligibility Criteria
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Inclusion Criteria
* Able to provide written, informed consent.
* Early Stage Breast Cancer (eBC) patients must have received at least 1 cycle of adjuvant anti-cancer therapy following surgery; metastatic breast cancer (mBC) patients must have received at least 1 cycle of treatment for their metastatic disease.
Exclusion Criteria
* Unable to complete written quality of life questionnaires
* Partcipants with Eastern Cooperative Oncology Group (ECOG) Performance Status ≥3
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Nevill Hall Hospital
Abergavenny, , United Kingdom
Colchester General Hospital
Colchester, Essex, , United Kingdom
Royal Devon & Exeter Hospital; Oncology Centre
Exeter, , United Kingdom
Royal Surrey County Hospital
Guildford, , United Kingdom
Ipswich Hospital; Clinical Oncology
Ipswich, , United Kingdom
Barts and the London NHS Trust.
London, , United Kingdom
St George's Hospital
London, , United Kingdom
Christie Hospital; Breast Cancer Research Office
Manchester, , United Kingdom
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Mount Vernon Cancer Centre
Northwood, , United Kingdom
Nottingham City Hospital; Oncology
Nottingham, , United Kingdom
Royal Cornwall Hospital
Truro, , United Kingdom
Pinderfields General Hospital
Wakefield, , United Kingdom
Yeovil District Hospital; Macmillan Cancer Unit
Yeovil, , United Kingdom
Countries
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Other Identifiers
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ML30098
Identifier Type: -
Identifier Source: org_study_id
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