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

Metastatic Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02595762
• Other study ID #: ML28801
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Breast Neoplasms
• Locally Advanced Breast Cancer
• Metastatic Breast Cancer

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