Clinical trial NCT02595762: A Study of Treatment Patterns and Outcomes in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
Official title: A Disease Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Breast Cancer
Locally Advanced Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-11-03
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Disease registry data will be collected among participants with HER2-positive unresectable LABC or MBC.

Brief summary: This disease registry is a prospective, multicenter non-interventional study designed to observe anti-cancer treatment regimens and clinical outcomes in participants with HER2-positive unresectable locally advanced breast cancer (LABC) or metastatic breast cancer (MBC).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of HER2-positive unresectable LABC or MBC within 6 months prior to enrollment

Exclusion Criteria:

* None specified

Primary outcomes:
measure: Percentage of Participants Receiving Each Unique Treatment Regimen Overall
timeFrame: Baseline up to approximately 8 years
measure: Percentage of Participants Receiving Each Unique Treatment Regimen as First-Line Versus Subsequent-Line Therapy
timeFrame: Baseline up to approximately 8 years
measure: Percentage of Participants Receiving Each Unique Treatment Regimen Sequence
timeFrame: Baseline up to approximately 8 years
measure: Progression-Free Survival (PFS)
timeFrame: From start date of anti-cancer treatment regimen to the date of either disease progression or death (up to approximately 8 years)
Secondary outcomes:
measure: Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
timeFrame: Baseline up to approximately 8 years
measure: Percentage of Participants Receiving Each Treatment Regimen, by Participant Characteristics
timeFrame: Baseline up to approximately 8 years
measure: Percentage of Participants Receiving Each Treatment Regimen, by Country/Region
timeFrame: Baseline up to approximately 8 years
measure: Overall Survival (OS)
timeFrame: From the date of initiation of treatment to the date of death from any cause (up to approximately 8 years)
measure: Number of Treatment Regimens Received
timeFrame: Baseline up to approximately 8 years
measure: Percentage of Participants With Complete Response (CR) or Partial Response (PR) - Objective Response Rate (ORR)
timeFrame: From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years)
measure: Duration of Response (DOR)
timeFrame: From date of first response (CR or PR) to the date of disease progression (up to approximately 8 years)
measure: Percentage of Participants by Reasons for Treatment Modification
timeFrame: Baseline up to approximately 8 years
measure: EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Score
timeFrame: Baseline up to approximately 8 years
measure: Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score
timeFrame: Baseline up to approximately 8 years
measure: Work Productivity and Activity Impairment-General Health (WPAI-GH) Questionnaire Score
timeFrame: Baseline up to approximately 8 years
measure: Percentage of Participants With HER2 Retesting
timeFrame: Baseline up to approximately 8 years
measure: Percentage of Participants With HER2 Overexpression, as Assessed Using In Situ Hybridization or Immunohistochemistry
timeFrame: Baseline up to approximately 8 years
measure: Healthcare Resource Utilization - Total Healthcare Cost
timeFrame: Baseline up to approximately 8 years
measure: Healthcare Resource Utilization - Percentage of Participants Who Are Hospitalized
timeFrame: Baseline up to approximately 8 years
measure: Healthcare Resource Utilization - Length of Hospitalization
timeFrame: Baseline up to approximately 8 years
measure: Healthcare Resource Utilization - Percentage of Participants With Emergency Room Visit
timeFrame: Baseline up to approximately 8 years
measure: Healthcare Resource Utilization - Percentage of Participants With Outpatient Visit
timeFrame: Baseline up to approximately 8 years
measure: Healthcare Resource Utilization - Cost of Disease Related Out-of-Pocket Healthcare Expenditures
timeFrame: Baseline up to approximately 8 years
measure: Healthcare Resource Utilization - Indirect Disease Related Cost
timeFrame: Baseline up to approximately 8 years
measure: Healthcare Resource Utilization - Number of Working Hours Missed Among Informal Caregivers due to Disease-Related Caregiving Responsibilities
timeFrame: Baseline up to approximately 8 years
measure: Healthcare Resource Utilization - Percentage of Participants Receiving Monetary Social Benefits
timeFrame: Baseline up to approximately 8 years
Other outcomes:
Locations:
city: Nicosia
country: Cyprus
facility: Bank of Cyprus Oncology Center
city: Athens
country: Greece
facility: Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
city: Athens
country: Greece
facility: Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine
city: Athens
country: Greece
facility: ARETAIEION UNIVERSITY HOSPITAL; oncology unit
city: Athens
country: Greece
facility: 251 Air Force General Hospital-Oncology Clinic
city: Athens
country: Greece
facility: Agioi Anargyroi; 3Rd Dept. of Medical Oncology
city: Athens
country: Greece
facility: IASO
city: Athens
country: Greece
facility: IASO General Hospital of Athens
city: Haidari
country: Greece
facility: Attikon University Hospital; 4th Department of Internal Medicine
city: Piraeus
country: Greece
facility: Metropolitan Hospital; 2Nd Oncology Clinic
city: Thessaloniki
country: Greece
facility: Theagenio Anticancer Hospital; 3Rd Oncology Clinic
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital; Medical Oncology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: