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

Completed

• Conditions: Locally Advanced Breast Cancer; Metastatic Breast Cancer

• Registration Number: NCT02595762
• Lead Sponsor: Hoffmann-La Roche

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-28
• Study First Submitted QC: 2015-11-02
• Study First Posted: 2015-11-03
• Study Start: 2016-10-30
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

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

Read More

Exclusion Criteria

• None specified

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Receiving Each Unique Treatment Regimen as First-Line Versus Subsequent-Line Therapy	Baseline up to approximately 8 years
Percentage of Participants Receiving Each Unique Treatment Regimen Overall	Baseline up to approximately 8 years
Percentage of Participants Receiving Each Unique Treatment Regimen Sequence	Baseline up to approximately 8 years
Progression-Free Survival (PFS)	From start date of anti-cancer treatment regimen to the date of either disease progression or death (up to approximately 8 years)	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.

Secondary Outcome Measures

Name	Time	Method
Number of Treatment Regimens Received	Baseline up to approximately 8 years
Percentage of Participants Receiving Each Treatment Regimen, by Country/Region	Baseline up to approximately 8 years
Overall Survival (OS)	From the date of initiation of treatment to the date of death from any cause (up to approximately 8 years)
Percentage of Participants by Reasons for Treatment Modification	Baseline up to approximately 8 years
Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score	Baseline up to approximately 8 years
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)	Baseline up to approximately 8 years
Percentage of Participants Receiving Each Treatment Regimen, by Participant Characteristics	Baseline up to approximately 8 years
Percentage of Participants With Complete Response (CR) or Partial Response (PR) - Objective Response Rate (ORR)	From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years)	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.
Duration of Response (DOR)	From date of first response (CR or PR) to the date of disease progression (up to approximately 8 years)	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.
EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Score	Baseline up to approximately 8 years
Percentage of Participants With HER2 Retesting	Baseline up to approximately 8 years
Healthcare Resource Utilization - Total Healthcare Cost	Baseline up to approximately 8 years
Healthcare Resource Utilization - Length of Hospitalization	Baseline up to approximately 8 years
Healthcare Resource Utilization - Percentage of Participants With Emergency Room Visit	Baseline up to approximately 8 years
Healthcare Resource Utilization - Percentage of Participants With Outpatient Visit	Baseline up to approximately 8 years
Healthcare Resource Utilization - Number of Working Hours Missed Among Informal Caregivers due to Disease-Related Caregiving Responsibilities	Baseline up to approximately 8 years
Healthcare Resource Utilization - Percentage of Participants Receiving Monetary Social Benefits	Baseline up to approximately 8 years
Work Productivity and Activity Impairment-General Health (WPAI-GH) Questionnaire Score	Baseline up to approximately 8 years
Percentage of Participants With HER2 Overexpression, as Assessed Using In Situ Hybridization or Immunohistochemistry	Baseline up to approximately 8 years
Healthcare Resource Utilization - Percentage of Participants Who Are Hospitalized	Baseline up to approximately 8 years
Healthcare Resource Utilization - Cost of Disease Related Out-of-Pocket Healthcare Expenditures	Baseline up to approximately 8 years
Healthcare Resource Utilization - Indirect Disease Related Cost	Baseline up to approximately 8 years

Trial Locations

Locations (12)

ARETAIEION UNIVERSITY HOSPITAL; oncology unit; 🇬🇷 Athens, Greece

Agioi Anargyroi; 3Rd Dept. of Medical Oncology; 🇬🇷 Athens, Greece

Attikon University Hospital; 4th Department of Internal Medicine; 🇬🇷 Haidari, Greece

251 Air Force General Hospital-Oncology Clinic; 🇬🇷 Athens, Greece

IASO General Hospital of Athens; 🇬🇷 Athens, Greece

Bank of Cyprus Oncology Center; 🇨🇾 Nicosia, Cyprus

Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine; 🇬🇷 Athens, Greece

Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine; 🇬🇷 Athens, Greece

IASO; 🇬🇷 Athens, Greece

Theagenio Anticancer Hospital; 3Rd Oncology Clinic; 🇬🇷 Thessaloniki, Greece

Papageorgiou General Hospital; Medical Oncology; 🇬🇷 Thessaloniki, Greece

Metropolitan Hospital; 2Nd Oncology Clinic; 🇬🇷 Piraeus, Greece