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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02595762
Other study ID # ML28801
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 30, 2016
Est. completion date September 30, 2024

Study information

Verified date March 2024
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 110
Est. completion date September 30, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of HER2-positive unresectable LABC or MBC within 6 months prior to enrollment Exclusion Criteria: - None specified

Study Design


Locations

Country Name City State
Cyprus Bank of Cyprus Oncology Center Nicosia
Greece 251 Air Force General Hospital-Oncology Clinic Athens
Greece Agioi Anargyroi; 3Rd Dept. of Medical Oncology Athens
Greece Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine Athens
Greece Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine Athens
Greece ARETAIEION UNIVERSITY HOSPITAL; oncology unit Athens
Greece IASO Athens
Greece IASO General Hospital of Athens Athens
Greece Attikon University Hospital; 4th Department of Internal Medicine Haidari
Greece Metropolitan Hospital; 2Nd Oncology Clinic Piraeus
Greece Papageorgiou General Hospital; Medical Oncology Thessaloniki
Greece Theagenio Anticancer Hospital; 3Rd Oncology Clinic Thessaloniki

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Cyprus,  Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants Receiving Each Unique Treatment Regimen Overall Baseline up to approximately 8 years
Primary Percentage of Participants Receiving Each Unique Treatment Regimen as First-Line Versus Subsequent-Line Therapy Baseline up to approximately 8 years
Primary Percentage of Participants Receiving Each Unique Treatment Regimen Sequence Baseline up to approximately 8 years
Primary Progression-Free Survival (PFS) Tumor response will be evaluated by the Investigator according to site-/country-specific medical practice. Study protocol does not specify any particular method of assessment. From start date of anti-cancer treatment regimen to the date of either disease progression or death (up to approximately 8 years)
Secondary Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) Baseline up to approximately 8 years
Secondary Percentage of Participants Receiving Each Treatment Regimen, by Participant Characteristics Baseline up to approximately 8 years
Secondary Percentage of Participants Receiving Each Treatment Regimen, by Country/Region Baseline up to approximately 8 years
Secondary Overall Survival (OS) From the date of initiation of treatment to the date of death from any cause (up to approximately 8 years)
Secondary Number of Treatment Regimens Received Baseline up to approximately 8 years
Secondary Percentage of Participants With Complete Response (CR) or Partial Response (PR) - Objective Response Rate (ORR) Tumor response will be evaluated by the Investigator according to site-/country-specific medical practice. Study protocol does not specify any particular method of assessment. From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years)
Secondary Duration of Response (DOR) Tumor response will be evaluated by the Investigator according to site-/country-specific medical practice. Study protocol does not specify any particular method of assessment. From date of first response (CR or PR) to the date of disease progression (up to approximately 8 years)
Secondary Percentage of Participants by Reasons for Treatment Modification Baseline up to approximately 8 years
Secondary EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Score Baseline up to approximately 8 years
Secondary Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score Baseline up to approximately 8 years
Secondary Work Productivity and Activity Impairment-General Health (WPAI-GH) Questionnaire Score Baseline up to approximately 8 years
Secondary Percentage of Participants With HER2 Retesting Baseline up to approximately 8 years
Secondary Percentage of Participants With HER2 Overexpression, as Assessed Using In Situ Hybridization or Immunohistochemistry Baseline up to approximately 8 years
Secondary Healthcare Resource Utilization - Total Healthcare Cost Baseline up to approximately 8 years
Secondary Healthcare Resource Utilization - Percentage of Participants Who Are Hospitalized Baseline up to approximately 8 years
Secondary Healthcare Resource Utilization - Length of Hospitalization Baseline up to approximately 8 years
Secondary Healthcare Resource Utilization - Percentage of Participants With Emergency Room Visit Baseline up to approximately 8 years
Secondary Healthcare Resource Utilization - Percentage of Participants With Outpatient Visit Baseline up to approximately 8 years
Secondary Healthcare Resource Utilization - Cost of Disease Related Out-of-Pocket Healthcare Expenditures Baseline up to approximately 8 years
Secondary Healthcare Resource Utilization - Indirect Disease Related Cost Baseline up to approximately 8 years
Secondary Healthcare Resource Utilization - Number of Working Hours Missed Among Informal Caregivers due to Disease-Related Caregiving Responsibilities Baseline up to approximately 8 years
Secondary Healthcare Resource Utilization - Percentage of Participants Receiving Monetary Social Benefits Baseline up to approximately 8 years
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