Implementing Geriatric Assessment for Dose Optimization of Cyclin-dependent Kinase (CDK) 4/6-inhibitors in Older Breast Cancer Patients
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
IMPORTANT study is a multicenter, open-label, prospective, randomized-controlled, non-inferiority trial with a pragmatic approach involving older patients (≥ 70 years old) with advanced hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer, not amenable for curative treatment and without prior therapy for advanced disease, who are suitable to receive CDK 4/6-inhibitors plus endocrine therapy as first line therapy. The study implements two approaches with high level of evidence, namely the use of comprehensive geriatric assessment (CGA) approach in treatment decision making and the use of CDK 4/6-inhibitors as the initial treatment of choice, to investigate whether a common clinical practice (starting dose reduction of CDK 4/6-inhibitors in older patients) with evidence of low certainty can be standardized using a more individualized-based approach. On the basis of baseline CGA assessment, patients will either receive full dose of CDK 4/6-inhibitors plus endocrine therapy (if patients are fit according to CGA) or be randomized to full dose vs. reduced initial dose of CDK 4/6-inhibitors (if vulnerable or frail according to CGA). The study hypothesis is that adjusting the dose according to vulnerability will allow patients to tolerate treatment better without jeopardizing the treatment efficacy. This project has received funding from the European Union's HORIZON 2022 research and innovation actions supporting the implementation of the Mission on Cancer under grant agreement No 101104589.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 70 lat w momencie wyrażenia zgody na uczestnictwo
- •Potwierdzona histologicznie lub cytologicznie nowotwór piersi dodatni na receptor hormonalny (≥ 1%) i ujemny na HER2
- •Zaawansowany nowotwór piersi (nawrót miejscowy lub przerzuty) niemożliwy do wyleczenia
- •Brak poprzedniego leczenia systemowego zaawansowanego raka; wcześniejsze leczenie inhibitorami aromatazy lub fulwestrantem przez maksymalnie 28 dni jest dozwolone
- •Uzasadnione choroby lub choroby tylko w kościach, możliwe do oceny selon kryteria RECIST 1.1
- •Pisemna świadoma zgoda przed rozpoczęciem procedur związanych z badaniem
- •Właściwe funkcjonowanie organów wewnętrznych zgodnie z charakterystyką leku
- •Zdolność do połykania kapsułek
✗ Disqualifies
- •Pacjent uznany przez lekarza za nienadający się do leczenia tym typem leków
- •Przeciwwskazania zgodnie z charakterystyką leku
- •Obecność krytycznego stanu narządów, zapalenia naczyń limfatycznych lub raka opon mózgowo-rdzeniowych
- •Historia innego nowotatoru (poza rakiem skóry bez melaniny lub rakiem in-situ szyjki macicy), chyba że w całkowitej remisji przez co najmniej 3 lata bez leczenia
- •Jednoczesne uczestnictwo w innym badaniu klinicznym
Simplified criteria — AI translation
Trial details
- Minimum age
- 70 Years
- Last updated (source)
- November 19, 2024
- Sex
- No restrictions
Therapies / drugs in trial
Locations (12)
Department of Oncology, Helsinki University Hospital Comprehensive Cancer Center and University of Helsinki
Helsinki, Finland
Fourth Oncology Department & Comprehensive Clinical Trials Center, Metropolitan Hospital
Athens, Greece
Second Department of Medical Oncology, Hygeia Hospital
Athens, Greece
Division of Oncology, Department of Medicine, University Hospital, University of Patras Medical School
Pátrai, Greece
Medical Oncology Unit, S. Andrew Hospital
Pátrai, Greece
Second Department of Medical Oncology, Euromedica General Clinic
Thessaloniki, Greece
Radiation Oncology Unit - Oncology Department, Azienda Ospedaliero Universitaria Careggi
Florence, Italy
"Sandro Pitigliani" Department of Medical Oncology, Hospital of Prato
Prato, Italy
Department of Oncology, Akershus University Hospital (AHUS)
Oslo, Norway
Department of Medical Oncology, Hospital Clinic of Barcelona
Barcelona, Spain
Department of Oncology, Örebro University Hospital
Örebro, Sweden
Department of Oncology, Uppsala University Hospital
Uppsala, Sweden
Trial contact
Antonios Valachis, Assoc Prof
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.