FourLight-3 - An Interventional, Open-Label, Randomized, Multicenter Phase 3 Study of PF-07220060 Plus Letrozole Compared to CDK4/6 Inhibitor Plus Letrozole in Participants Over 18 Years of Age With Hormone Receptor (HR)-Positive, HER2-Negative Advanced/Metastatic Breast Cancer who Have not Received any Prior Systemic Anticancer Treatment for Advanced/Metastatic Disease (C4391024)

Studio Clinico

Patologia: Neoplasie della mammella

Osservazionale-Sperimentale: Sperimentale

Randomizzato: Sì

Fase di studio: III

Linee di trattamento: Prima linea

Criteri di inclusione: 

- Histological confirmation of breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent.
- Documented estrogen receptor (ER) and/or progesterone receptor (PR)-positive tumor
- Documented HER2-negative tumor
- Previously untreated with any systemic anticancer therapy for their locally advanced or metastatic disease.
- Measurable disease or non-measurable bone only disease as defined by RECIST version 1.1.

Criteri di esclusione: 

- In visceral crisis at risk of immediately life-threatening complications in the short term.
- Current or past history of central nervous system metastases.
- Have received prior (neo)adjuvant endocrine therapy (ET) and had recurrence during or within 12 months after the last dose of ET.
- Have received prior (neo)adjuvant CDK4/6i and had recurrence during or within 12 months after the last dose of CDK4/6i.
- Inadequate renal function, hepatic dysfunction, or hematologic abnormalities.

Numero di pazienti previsti: 

24

Schema di trattamento: 

Experimental: Arm A
PF-07220060 (CDK4 inhibitor) tablet taken by mouth plus Letrozole tablet taken by mouth

Active Comparator: Arm B
Investigator's Choice of CDK4/6 inhibitor: abemaciclib - palbociclib - ribociclib (tablet/capsule) taken by mouth with letrozole tablet taken by mouth.

Trattamento sperimentale: 

PF-07220060 (CDK4 inhibitor) tablet taken by mouth plus Letrozole

Trattamento di controllo: 

Investigator's Choice of CDK4/6 inhibitor (abemaciclib/palbociclib/ribociclib) taken by mouth with letrozole

Obiettivi primari dello studio: 

Progression Free Survival (PFS) by BICR

Data di inizio dell'arruolamento: 01.06.2025

Data di fine dell'arruolamento: 29.06.2026

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2024-512925-95-00

Data di inserimento: 23.06.2025

Promotore

Pfizer

Principal Investigator ITALIA

Riferimento: Dr. Info non applicabile

Telefono: 00000

Email: na@na.it

Localita: na