IMPlementing geriatric assessment for dose Optimization of CDK 4/6-inhibitors in older bReasT cAncer patieNTs
About this project
Project information
A breast cancer study has received SEK 67 million from the EU's Horizon Europe framework program. Eleven European countries are included and researcher Antonios Valachis at Örebro University Hospital is coordinating the study, Antonios is an affiliated researcher at Örebro University. The research is aimed at the patient group of women over 70.
The study called IMPORTANT, will be the first in the world to investigate whether a lower dose of a targeted treatment called a CDK 4/6 inhibitor works in older patients with disseminated hormone-sensitive breast cancer.
Drugs that block cancer cells CDK 4/6 is a new category of drugs launched six years ago. It blocks the cancer cells so they cannot continue in the cell cycle. Usually, treatment for these patients is a combination of antihormonal therapy and the targeted therapy CDK 4/6 inhibitors. The inhibitor is given as tablets and it is given as a standard dose to all patients.
However, it has been seen that elderly patients run a greater risk of side effects if they receive a full dose of CDK 4/6 inhibitors. In the study, we will use an assessment tool to see if elderly patients are in good condition or poor condition, and if they are poor, they will be randomized to either a lower dose of CDK 4/6 inhibitor or the standard dose. Hope is that a lower dose will give just as good an effect. The study includes 19 partners from the eleven participating countries. 500 patients will be recruited from Sweden, Norway, Finland, Italy, Spain, and Greece. The study is expected to last for five years.
The aim and hope of the study are to be able to prove that a lower dose of CDK 4/6 inhibitors in elderly and fragile breast cancer patients is at least as good as the full dose but with fewer side effects. In that is the case, it will change clinical practice and we will be able to improve the ability to treat our elderly, frail patients. Fewer side effects will mean less need for care and a better quality of life for these patients.
Researchers
Collaborators
- Azienda Usl Toscana centro
- CARE ACROSS LTD (CARE)
- CIRCULAR ECONOMY FOUNDATION (CEF)
- ELLINIKI SYNERGAZOMENI OGKOLOGIKI OMADA (HECOG)
- EUNOMIA LIMITED (EUNL)
- Helsingfors universitetssjukhus (Hus)
- HOSPITAL CLINIC DE BARCELONA (HCB)
- Institute for Medical Technology assessment
- Phaze clinical research & pharma
- Region Uppsala
- Region Örebro County
- Security Labs consulting
- Swedish Breast Cancer association
- UNIVERSIDAD NACIONAL DE EDUCACION A DISTANCIA (UNED)
- Universita degli studi Firenze
- University of applied Sciences and Arts Northwestern Switzerland
- University of Patras