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

Obiettivi primari dello studio: 

Progression Free Survival (PFS) [Time Frame: From randomization date (every 8 weeks for the first 48 weeks and then every 12 weeks thereafter) to date of first documentation of progression OR death (approximately 2 years).]
Progression-free survival is defined as the time interval from the date of randomization to the date of first documented tumor progression determined by blinded independent central review (BICR) assessment as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or death due to any cause, whichever come first.

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

Data di aggiornamento: 09.10.2023

Promotore

Pfizer

CRO

PPD

Principal Investigator ITALIA

Riferimento: Dr. Info non disponibile

Telefono: 00000

Email: nd@nd.it

Localita: nd