IMPORTANT Trial - Implementing Geriatric Assessment for Dose Optimization of CDK 4/6-inhibitors in Older Breast Cancer Patients - a Pragmatic Randomized-controlled Trial

Studio Clinico

Patologia: Neoplasie della mammella

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: Sì

Fase di studio: III

Linee di trattamento: Prima linea

Criteri di inclusione: 

- Patients male or female aged at least 70 years old at the time of informed consent. Male patients should use adequate contraceptive methods (e.g., double-barrier contraception) during therapy and for at least 14 weeks after completing therapy.
- Able to understand and consent in English language or in native language for each participating country.
- Histologically or cytologically confirmed diagnosis of HR-positive (defined as estrogen-receptor ≥ 1%), HER2-negative breast cancer according to analysis of the most recent tumor specimen by local laboratory.
- Advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative treatment.
- No prior systemic treatment for advanced disease (recurrence during neo-/adjuvant endocrine therapy is allowed). A prior period of treatment with aromatase inhibitors or fulvestrant for up to 56 days from the CDK 4/6-inhibitor initiation is allowed as long as there is no disease progression during this time period.
- Adjuvant treatment with CDK4/6-inhibitors is allowed provided a disease-free interval from treatment end >12 months.
- Written informed consent prior to any study-specific procedures.
- Adequate organ function as defined in the summary of product characteristics (SmPC) for the CDK 4/6-inhibitors that is planned to be used including ECG for assessment of QT interval before treatment with ribociclib.
- Able to swallow capsules.

Criteri di esclusione: 

- Patients considered from treating physician as non-suitable for treatment with CDK 4/6-inhibitors.
- Contraindications according to SmPC for the CDK 4/6-inhibitors that is planned to be used.
- History of any other cancer (except of non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years.
- Participating in other interventional trial.
- Patients with cognitive impairment (as assessed by treating physician) that preclude the ability to fill out the self-reported CGA.

Trattamento sperimentale: 

Lower initial dose of CDK 4/6-inhibitor

Endocrine therapy

Trattamento di controllo: 

Full initial dose of CDK 4/6-inhibitor

Endocrine therapy

Centri partecipanti

Centro Italia

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2023-506620-87-00 - NCT06044623

Data di inserimento: 03.12.2025

Promotore

Region Örebro County

Principal Investigator ITALIA

Riferimento: Dr. Info non disponibile

Telefono: 00000

Email: nd@nd.it

Localita: nd