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

August 15, 2024 updated by: Hoffmann-La Roche

A Disease Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cyprus
      • Nicosia, Cyprus, 2006
        • Bank of Cyprus Oncology Center
  • Greece
      • Athens, Greece, 145 64
        • Agioi Anargyroi; 3Rd Dept. of Medical Oncology
      • Athens, Greece, 115 22
        • Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
      • Athens, Greece, 155 62
        • IASO General Hospital of Athens
      • Athens, Greece, 115 28
        • ARETAIEION UNIVERSITY HOSPITAL; oncology unit
      • Athens, Greece, 115 22
        • Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine
      • Athens, Greece, 151 23
        • IASO
      • Athens, Greece, 11525
        • 251 Air Force General Hospital-Oncology Clinic
      • Haidari, Greece, 124 62
        • Attikon University Hospital; 4th Department of Internal Medicine
      • Piraeus, Greece, 185 47
        • Metropolitan Hospital; 2Nd Oncology Clinic
      • Thessaloniki, Greece, 564 29
        • Papageorgiou General Hospital; Medical Oncology
      • Thessaloniki, Greece, 546 39
        • Theagenio Anticancer Hospital; 3Rd Oncology Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Disease registry data will be collected among participants with HER2-positive unresectable LABC or MBC.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Participants With HER2-Positive Breast Cancer
Enrolled participants will receive treatment and clinical assessments for their HER2-positive unresectable LABC/MBC as determined by their treating physician, according to the standard of care and routine clinical practice at each site. Participants will be followed until death, withdrawal of consent or study termination, whichever occurs first. Study protocol does not specify any particular drug or treatment regimen.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2016

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

November 30, 2023

Study Registration Dates

First Submitted

October 28, 2015

First Submitted That Met QC Criteria

November 2, 2015

First Posted (Estimated)

November 3, 2015

Study Record Updates

Last Update Posted (Actual)

August 19, 2024

Last Update Submitted That Met QC Criteria

August 15, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML28801

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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