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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: 

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

IRCCS - IRST Meldola Dino Amadori
Via P. Maroncelli 40 - 47014 Meldola - FC

Riferimento: Dr. Ugo De Giorgi
Telefono: 0543739100
Email: ugo.degiorgi@irst.emr.it

 

Ospedale San Raffaele di Milano
Via Olgettina 60 - 20132 Milano - MI
Oncologia Medica

 

Azienda Ospedaliera Santa Maria della Misericordia
Piazzale Santa Maria della Misericordia 15 - 33100 Udine - UD
NB: Arruolamento pazienti non ancora attivo

 

Centro Italia

A.U.S.L. 9 Grosseto
Via Senese - 58100 Grosseto - GR
Ospedale Misericordia - Dipartimento di Oncologia - NB: Arruolamento pazienti non ancora attivo

Riferimento: Dr. Carmelo Bengala
Telefono: 0564485286
Email: carmelo.bengala@uslsudest.toscana.it

 

Ospedale Belcolle
Strada Sammartinese - 01100 Viterbo - VT
NB: Arruolamento pazienti non ancora attivo

 

Sud Italia e isole

Istituto Tumori “Giovanni Paolo II” IRCCS
Viale Orazio Flacco 65 - 70124 Bari - BA
NB: Arruolamento pazienti non ancora attivo

 

Humanitas Istituto Clinico Catanese
St.Provinciale 54, n. 11 - 95045 Contrada Cubba, Misterbianco (Catania) - CT

Riferimento: Dr. Michele Caruso
Telefono: 09573390167
Email: michele.caruso@ccocatania.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2021-002301-10

Data di inserimento: 22.07.2022

Promotore

Eli Lilly

Principal Investigator ITALIA

Ospedale San Raffaele, Milano

Riferimento: Prof. Giampaolo Bianchini

Telefono: 026436530

Email: bianchini.giampaolo@hsr.it

Localita: Milano

 

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