Breast Cancer Registry Platform

Study Overview
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Brief Summary
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The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study with associated satellites, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with breast cancer in Germany.

Detailed Description
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OPAL is a national, observational, prospective, longitudinal, multicenter cohort study (tumor registry platform) with the purpose to record information on the antineoplastic treatment of breast cancer in Germany. The registry will follow patients for up to five years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented. Health-related quality of life in patients with breast cancer will be evaluated for up to five years.

Official Title
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Treatment and Outcome of Patients With Breast Cancer: Clinical Research Platform for Real World Data

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: EBC cohort: Female and male patients with early breast cancer (stage I-III defined as breast cancer that has not spread beyond the breast or the axillary lymph nodes) Patients at the start of their initial systemic treatment for EBC, i.e. at start of neoadjuvant treatment for patients receiving neoadjuvant thera-py or at start of adjuvant treatment if no neoadjuvant therapy is given. Treatment can be cytotoxic, endocrine, or targeted substances, what-ever was given first ABC cohort: Female and male patients with advanced breast cancer (stage IV defined as synchronous or metachronous diagnosis of distant metastases at inclusion) Patients at the start of their initial first-line systemic treatment for ABC, which can be cytotoxic, endocrine or targeting a specific signaling pathway, whatever is given first All cohorts: Written informed consent Patients participating in the PRO module: signing of informed consent form and completion of baseline questionnaire before start of initial systemic treatment for EBC or systemic first-line treatment for ABC Patients not participating in the PRO module: within six weeks after start of initial systemic treatment for EBC or systemic first-line treatment for ABC Age ≥ 18 years Exclusion Criteria: Patients with prior systemic therapy (cytotoxic, endocrine, or targeted) for EBC or ABC Patients who do not receive any systemic therapy for EBC or ABC

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Advanced breast cancer - Her2 positive<br>Patients with HER2-positive advanced breast cancer | |
| Advanced breast cancer - triple negative<br>Patients with triple negative advanced breast cancer | |
| Advanced breast cancer - HR positive, Her2 negative<br>Patients with HR positive, Her2 negative advanced breast cancer | |
| Early breast cancer - HER2 positive<br>Patients with HER2 positive early breast cancer | |
| Early breast cancer - triple negative<br>Patients with triple negative early breast cancer | |
| Early breast cancer - HR positive, HER2 negative<br>Patients with HR positive, HER2 negative early breast cancer | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment reality | Description of treatment reality (Course of systemic treatments and sequential treatments) applied in German routine practice measured as the frequency of the various systemic treatments applied per line of therapy. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Response | Documentation of response rates per line of treatment. | 5 years | 
| Progression-free survival | Documentation of progression-free survival per line of treatment. | 5 years | 
| Overall survival | Documentation of date of death. | 5 years | 
| Health-related quality of life (Patient-reported outcome) | EORTC QLQ-C30 core questionnaire and additional items. | 3.5 years | 
| Disease-free survival | Documentation of disease-free survival. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Epidemiology, Registry, Health Services Research, Germany, Palliative Treatment, Adjuvant Treatment, Neoadjuvant Treatment