Clinical trial NCT03099200: An Observational Study Evaluating the Productivity and Health-Related Quality of Life of People With HER2 Positive Breast Cancer
Official title: UK HER2 Positive Breast Cancer Productivity & Utility Non-Interventional Study (PURPOSE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2017-04-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with HER2 positive early breast cancer currently receiving adjuvant treatment (with chemotherapy and/or targeted HER2 therapy), or have completed treatment and in disease-free survival, or receiving treatment for metastatic breast cancer will be observed.

Brief summary: The purpose of this study is to compare productivity (in terms of work or daily activity) and generic and disease-specific health-related quality of life of participants with HER2 positive early breast cancer currently receiving adjuvant treatment (with chemotherapy and/or targeted HER2 therapy), with participants who have completed adjuvant parenteral therapy, and participants with HER2 positive metastatic breast cancer.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with early stage or metastatic (Stage IV) HER2-positive breast cancer (confirmed by the study site physician). \[HER2-positive is defined as ImmunoHistoChemistry (IHC3+) and/or in situ hybridization (ISH) ≥2.0\]
* 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:

* Unwilling or unable to consent.
* Unable to complete written quality of life questionnaires
* Partcipants with Eastern Cooperative Oncology Group (ECOG) Performance Status ≥3

Primary outcomes:
measure: A Comparison of Productivity, Assessed by Patient-Reported Work Productivity and Activity Impairment (WPAI) Questionnaire Score, of Participants in Cohort 1 vs Cohort 2 vs Cohort 3
timeFrame: Baseline
Secondary outcomes:
measure: A Comparison of Generic Health Related Quality of Life (HRQoL), Assessed by EuroQoL Health Related Quality of Life - 5 Dimensions - 5 Levels (EQ-5D-5L) Score, of Participants in Cohort 1 vs Cohort 2 vs Cohort 3
timeFrame: Baseline
measure: A Comparison of Disease-Specific HRQoL, Assessed by Functional Assessment of Cancer Therapy-Breast (FACT-B) Score, of Participants in Cohort 1 vs Cohort 2 vs Cohort 3
timeFrame: Baseline
Other outcomes:
Locations:
city: Abergavenny
country: United Kingdom
facility: Nevill Hall Hospital
city: Colchester, Essex
country: United Kingdom
facility: Colchester General Hospital
city: Exeter
country: United Kingdom
facility: Royal Devon & Exeter Hospital; Oncology Centre
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
city: Ipswich
country: United Kingdom
facility: Ipswich Hospital; Clinical Oncology
city: London
country: United Kingdom
facility: Barts and the London NHS Trust.
city: London
country: United Kingdom
facility: St George's Hospital
city: Manchester
country: United Kingdom
facility: Christie Hospital; Breast Cancer Research Office
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital; Oncology
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
city: Wakefield
country: United Kingdom
facility: Pinderfields General Hospital
city: Yeovil
country: United Kingdom
facility: Yeovil District Hospital; Macmillan Cancer Unit
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: