C4551002 - An Interventional, Open-Label, Randomized, Multicenter, Phase 3 Study of PF-07248144 Plus Fulvestrant Compared to Investigator's Choice of Therapy in Adult Participants With Hormone Receptor-Positive, HER2-Negative Advanced/Metastatic Breast Cancer Whose Disease Progressed After Prior CDK4/6 Inhibitor-based Therapy

Studio Clinico

Patologia: Neoplasie della mammella

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: Sì

Fase di studio: III

Linee di trattamento: Seconda linea

Criteri di inclusione: 

- Confirmed diagnosis of HR-positive HER2-negative breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent.
- Prior CDK4/6 inhibitor therapy in combination with endocrine therapy in advance metastatic setting or in adjuvant setting with documented progression during or within 12 months after the last dose of CDK4/6i.
- Participants are eligible if they previously received CDK4/6i or ET as a monotherapy, or in combination for rechallenge therapy in the advance or metastatic setting; have received prior therapy targeting estrogen receptor 1 (ESR1) or breast cancer gene (BRCA)1/2.
- Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.

Criteri di esclusione: 

- Documented detectable PIK3CA/AKT1/PTEN alterations in tissue
- Received greater than two prior lines of systemic therapy in the advance or metastatic setting
- Had received any prior chemotherapy, including antibody drug conjugates (ADCs), in advance or metastatic setting. Participants who have previously received chemotherapy in the (neo)adjuvant setting are not excluded from the study.
- Any medical or psychiatric condition that may increase the risk of study participation or make the participant inappropriate for the study.
- Renal impairment, hepatic dysfunction, or hematologic abnormalities.

Numero di pazienti previsti: 

10

Schema di trattamento: 

Experimental: Arm A:
PF-07248144 plus fulvestrant. PF-07248144 tablet taken by mouth plus fulvestrant taken as a shot into the muscle

Active Comparator: Arm B:
everolimus plus ET. Everolimus tablet taken by mouth plus investigator's choice of endocrine therapy of exemestane tablet taken by mouth or fulvestrant taken as a shot into the muscle. Endocrine therapy: Fulvestrant - Exemestane. mTOR inhibitor: Everolimus.

Trattamento sperimentale: 

PF-07248144 (KAT6 inhibitor)

Trattamento di controllo: 

everolimus plus ET

Obiettivi primari dello studio: 

Progression Free Survival (PFS) as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2025-520566-22-00

Data di inserimento: 13.02.2026

Promotore

Pfizer

Principal Investigator ITALIA

Riferimento: Dr. - -

Telefono: 00000

Email: na@na.it

Localita: -