This oncologic clinical trial evaluates the efficacy and safety of the CDK 4/6 Inhibitor Abemaciclib in combination with endocrine therapy in high-risk early breast cancer patients
Cologne, Germany, 07.01.2021 – CANKADO, the leading digital health application developers in Germany, assists the recently started clinical trial, ADAPTlate, organized by West German Study Group (WSG) to collect the Patient Reported Outcomes (PROs) by the CANKADO ePRO tool. The clinical trial already enrolled the first patients who are using the CANKADO e-Health system as part of the study to monitor their Quality of Life (QoL). The trial aims to gain further knowledge on the efficacy and safety of the Abemaciclib treatment in combination with endocrine therapy versus standard endocrine therapy in HR+/HER2- early breast cancer patients with high risk for disease recurrence.
WSG is a research facility in Germany focusing on the design, organization and implementation of clinical trials for breast cancer patients. The first ADAPT trial (NCT01779206) and its findings have gained positive national and international feedback. ADAPTlate, which is a multicentre phase 3 trial as part of the ADAPT trial program, enrolls breast cancer patients who are at high risk of disease recurrence. Standard-of-care for these patients are chemotherapy and at least 5 years of endocrine therapy. But it has been proved that these patients only receive minimum benefit from these standard therapies. Additionally, they commonly develop resistance against endocrine therapy at the time of cancer recurrence. Thus, ADAPTlate evaluates if the high-risk patient group gains additional benefit if treated with Abemaciclib in combination with endocrine therapy compared to the treatment with endocrine therapy alone.
ADAPTlate uses the CANKADO e-Health platform to record the patient reported outcomes (PROs). Patients record their PRO data directly at the study sites by answering questionnaires digitally at a study-specific tablet. The thereby collected data is forwarded to the study group for further analysis. With the patient reported data, the study objectives and quality of life are analysed. CANKADO’s digital health solution allows an effective way to document electronic patient reported outcomes or ePRO.
CANKADO’s e-Health system is specifically adapted according to the protocol requirements and supports multilingual usage. Therefore, the system is highly suitable to be used in the conduct of clinical trials and projects. Additionally, the CANKADO ePRO tool enables the efficient management of multiple assessments, which are easily accessible to patients.
The West Study Group GmbH (WSG) is a research facility in Germany focusing on the design, organization and implementation of clinical trials for breast cancer patients. The aim of the studies is to develop therapies that improve the chances of recovery and tolerability compared to the current standard therapy. The ADAPT trial program is one of the first new generation trials addressing the issue of individualization of treatment decision-making in early breast cancer in a subtype-specific manner. The goals are to establish an early response assessment and subtype-specific therapies tailored to those patients who are most likely to benefit.
CANKADO is a digital health platform with a web/app multilingual system. It is registered as a medical device in the European Union and compliant with the FDA classification for Mobile Medical Devices. CANKADO offers digital health solutions and develops new tools specific to the requirements and outputs of each project. It runs with a wide range of clientele that mostly covers pharmaceutical companies and Clinical Research Organisations (CROs). Click here to enquire further information regarding CANKADO’s digital health services.
CANKADO Service GmbH, headquartered in Germany, operates with over 50 employees with six offices in four countries and has project experience on all continents. CANKADO is the worldwide leading system for multi-lingual support of patients with chronic diseases in routine care and in clinical trials, also offering various digital health solutions in the areas of cancer, diabetes, cardiology, surgery, cell therapy, psychology, and nutrition.
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