C4891001 - A phase 3, randomized, open-label, multicenter trial of ARV-471 (PF-07850327) vs Fulvestrant in participants with estrogen receptor-positive, HER2-negative advanced breast cancer whose disease progressed after prior endocrine based treatment for advanced disease (VERITAC-2)

Studio Clinico

Patologia: Neoplasie della mammella

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: Sì

Fase di studio: III

Richiesta mandatoria di tessuto: Sì

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

- Adult participants with loco-regional recurrent or metastatic breast disease not amenable to surgical resection or radiation therapy
- Confirmed diagnosis of ER+/HER2- breast cancer
- Prior therapies for locoregional recurrent or metastatic disease must fulfill all the following criteria:
- One line of CDK4/6 inhibitor therapy in combination with endocrine therapy
- ≤ 1 endocrine therapy in addition to CDK4/6 inhibitor with ET
- Most recent endocrine treatment duration must have been given for ≥6 months prior to disease progression
- Radiological progression during or after the last line of therapy
- 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 0-1
- Participants should be willing to provide blood and tumor tissue.

Criteri di esclusione: 

- Participants with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term
- Prior treatment with:
- ARV-471, fulvestrant, mTOR, PI3K, AKT pathway inhibitors, PARP inhibitor for any setting
- other investigational novel endocrine therapy (ie, SERD, SERCA, CERAN) for any setting
- prior CDK4/6 inhibitor treatment in the neoadjuvant/ adjuvant setting
- prior chemotherapy for advanced/metastatic disease
- Inadequate liver, kidney and bone marrow function
- Active brain metastases
- Participants with significant concomitant illness.

Numero di pazienti previsti: 

23 (in Italia)

Schema di trattamento: 

Arm A: ARV-471 (PF-07850327)
continuous dosing schedule
Arm B: Fulvestrant
intramuscularly on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle starting from C2D1 (28-day cycle).

Trattamento sperimentale: 

ARV-471

Trattamento di controllo: 

Fulvestrant

Data di inizio dell'arruolamento: 15.06.2023

Data di fine dell'arruolamento: 02.07.2024

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2022-500544-38-00 - NCT05654623

Data di inserimento: 05.07.2023

Promotore

Pfizer

CRO

PPD

Principal Investigator ITALIA

Riferimento: Dr. Info non disponibile

Telefono: 00000

Email: nd@nd.it

Localita: nd