Breast Cancer Registry Platform

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Treatment reality [Срок оценки: 5 years]

Вторичные конечные точки (5)

• Best Response [Срок оценки: 5 years]
• Progression-free survival [Срок оценки: 5 years]
• Overall survival [Срок оценки: 5 years]
• Health-related quality of life (Patient-reported outcome) [Срок оценки: 3.5 years]
• Disease-free survival [Срок оценки: 5 years]

Критерии участия

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 therapy or at start of adjuvant treatment if no neoadjuvant therapy is given. Treatment can be cytotoxic, endocrine, or targeted substances, whatever was given first

ABC cohort I (prospective):

• Female and male patients with advanced breast cancer (stage IV defined as synchrone or metachrone 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

ABC cohort II (retrospective):

• Confirmed diagnosis of HR-positive, HER2-negative ABC (stage IV defined as synchrone or metachrone diagnosis of distant metastases at inclusion)
• Start of initial first-line systemic treatment for ABC, which can be cytotoxic, endocrine or targeting a specific signaling pathway, whatever is given first, between September 2021 and December 2025
• Inclusion is possible regardless of whether patients are alive or deceased at the time of documentation; for patients alive: written informed consent

Prospective 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
• All 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

All cohorts:

• Age ≥ 18 years

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 1 центр

• Multiple sites all over germany — Many Locations

Публикации

• Marschner P, Ringwald K, Thill M, Zahn MO, Welt A, Nusch A, Kaltenecker G, Rodemer Y, Hagen V, Schock C, Kruggel L, Kaiser-Osterhues A, Klein D, Haug N, Stickeler E, Harbeck N, Wockel A, Marschner N, Decker T; OPAL Registry Group. Prediction of dose reductions and impact of reduced starting doses of CDK4/6i on effectiveness in HR-positive/HER2-negative metastatic breast cancer: Real-world data fro PMID 41851017
• Thill M, Zahn MO, Welt A, Nusch A, Zaiss M, Engelken K, Kaltenecker G, Ringwald K, Gratzke K, Dille S, Kruggel L, Janicke M, Schulz H, Hagen V, Fricker R, Stickeler E, Harbeck N, Wockel A, Decker T. Head-to-head comparison of palbociclib and ribociclib in first-line treatment of HR-positive/HER2-negative metastatic breast cancer with real-world data from the OPAL registry. Int J Cancer. 2025 May 1 PMID 39707595
• Thill M, Zahn MO, Welt A, Stickeler E, Nusch A, Fietz T, Rauh J, Wetzel N, Kruggel L, Janicke M, Marschner N, Harbeck N, Wockel A, Decker T; OPAL study group. Treatment and outcome in metastatic lobular breast cancer in the prospective German research platform OPAL. Breast Cancer Res Treat. 2023 Apr;198(3):545-553. doi: 10.1007/s10549-023-06882-7. Epub 2023 Feb 18. PMID 36807725

Идентификаторы

NCT: NCT03417115 · IOM-100361 · Registerplattform OPAL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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