PostMONARCH - A randomized Double Blind phase 3 Placebo control study to compare the efficacy of Abemaciclib + Fulvestrant to Placebo + Fulvestrant in HR+ HER2- MBC patients following progression on CDK 4/6 and endocrine therapy - I3Y-MC-JPEF

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: 

- Have a diagnosis of HR+, HER2- locally advanced or metastatic breast cancer
- Have radiologic evidence of disease progression or recurrence either:
- On treatment with a CDK4/6 inhibitor with aromatase inhibitor (AI) as initial therapy for advanced disease, or
On/after treatment with a CDK4/6 inhibitor plus endocrine therapy (ET) administered as adjuvant therapy for early stage breast cancer
- Must be deemed appropriate for treatment with ET
- If female, have a postmenopausal status by natural or surgical means
- Have Response Evaluable Criteria in Solid Tumors (RECIST) evaluable disease (measurable disease and/or nonmeasurable disease)
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982)
- Have adequate renal, hematologic, and hepatic organ function
- Must be able to swallow capsules/tablets

Criteri di esclusione: 

- Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis
- Have symptomatic or untreated central nervous system metastasis
- Have received any systemic therapy between disease recurrence/progression and study screening
- Have received more than 1 line of therapy for advanced or metastatic disease.
- Have received prior chemotherapy for metastatic breast cancer (MBC)
- Have received prior treatment with fulvestrant, any investigational estrogen receptor (ER)-directed therapy (including selective ER degraders [SERDs] and non-SERDs), any phosphatidylinositol 3-kinase (PI3K)-, mammalian target of rapamycin (mTOR)-, or protein kinase B (AKT)-inhibitor.

Trattamento sperimentale: 

abemaciclib (Verzenios) + Fulvestrant

Trattamento di controllo: 

Placebo +Fulvestrant

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2021-002301-10

Data di inserimento: 22.07.2022

Data di aggiornamento: 10.11.2022

Promotore

Eli Lilly

Principal Investigator ITALIA

Ospedale San Raffaele, Milano

Riferimento: Prof. Giampaolo Bianchini

Telefono: 026436530

Email: bianchini.giampaolo@hsr.it

Localita: Milano