ERYT/CoordiFit-Study
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Title in German |
Wirksamkeit von Bewegungstherapie gegen Fatigue (chronische Müdigkeit) bei Patientinnen mit metastasierter Brustkrebserkrankung |
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Title in English |
Effect of slow movement therapy in the treatment of fatigue in metastatic breast cancer patients |
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Description |
In this study, 196 patients are randomly assigned to either the ERYT (eurythmy therapy) or CoordiFit (gentle fitness training) group. The exercise period lasts 20 weeks for each participant, and two follow-up observations (online questionnaires) take place after 6 and 12 months. |
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Head Clinical Trial |
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Status |
open since 08.06.2020 |
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BASEC Nummer |
2019-01455 |
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KOFAM |
SNCTP000003525 |
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WHO-Register-Nummer |
NCT04024267 |
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Insel-Nummer |
4326 |
Serena 6
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Title in German |
Eine Phase III Studie zur Bewertung einer Umstellung auf Camizestrant (AZ9833) und einen CDK4/6 Hemmer im Vergleich zu einer Fortsetzung der Standardbehandlung mit einem Aromatase Hemmer und CDK4/6 Hemmer bei Patient/innen mit HR-positivem/HER-negativem metastasierten Mammakarzinom und ctDNA-Nachweis einer ESR1-Mutation ohne Krankheitsprogression während der Erstlinientherapie (SERENA-6) |
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Title in English |
A Phase III, Double-blind, Randomised Study to Assess Switching to AZD9833 (a Next Generation, Oral SERD) + CDK4/6 Inhibitor (Palbociclib or Abemaciclib) vs Continuing Aromatase Inhibitor (Letrozole or Anastrozole) + CDK4/6 Inhibitor in HR+/HER2- MBC Patients with Detectable ESR1 Mutation Without Disease Progression During 1L Treatment with Aromatase Inhibitor + CDK4/6 Inhibitor - A ctDNA Guided Early Switch Study |
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Description |
This study will be carried out at around 220 hospitals in around 25 countries. In Switzerland, three hospitals are involved. The study is designed to determine the effectiveness and safety of a study drug AZ9833 called Camizestrant in patients with HR-positive/HER-negative breast cancer with secondary tumors. This test is intended to find out whether it is better to replace the common aromatase inhibitor with calmizestrant as standard treatment. There is currently no way to determine which patients will benefit longest from standard treatment. It might be possible to identify patients for whom treatment no longer works by looking for cancer DNA in their blood to detect changes in the cancer genes. These changes occur before a tumor can be visualized using standard imaging techniques (e.g. CT or MRI scans). Around 2000 patients will be included in the first preliminary examination of the study. The study is divided into different phases: -The first preliminary examination checks whether the participants are suitable for the study. After the first preliminary investigation has been completed, the monitoring phase begins with appropriate suitability. This is used to check the changes in the cancer genes (ESR1 mutation). If no ESR1 mutations are present, the surveillance phase will continue until the cancer progresses or enough patients have been enrolled in the study. -If ESR1 mutations have been detected, the second preliminary examination will be carried out to check further suitability for treatment. It is planned that 300 patients worldwide (3 patients in Switzerland) will receive this treatment as part of the study. The treated patients are randomly assigned to one of two treatment groups in a 1:1 ratio. Treatment in both groups will continue until the disease progresses. |
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Phase/Biobank/ect. |
III |
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Head Clinical Trial |
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Study-Nurse |
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Study-Nurse |
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Status |
aktive since 02.08.2022, Part 1 abgeschlossen: 25.04.2024 |
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BASEC Nummer |
2021-01703 |
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KOFAM |
SNCTP000005068 |
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WHO-Register-Nummer |
NCT04964934 |
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Insel-Nummer |
5199 |