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A Study of LY3295668 erbumine in Patients with Metastatic Breast Cancer after CDK4/6 Inhibitor and Endocrine Therapy - J1O-MC-JZHC

Studio Clinico

Patologia: Neoplasie della mammella

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: I,

Linee di trattamento: Seconda linea

Criteri di inclusione: 

· Have histological or cytological evidence, prior to this study’s pre-treatment biopsy, of a diagnosis of locally advanced or mBC. On-study pre-treatment biopsy results will not preclude enrollment.
· Patient’s tumor must be HR+: expression of the estrogen receptor (ER) or progesterone receptor (PR) is >1% by immunohistochemistry (IHC); and HER2−: either 0 to 1+ by IHC or 2+ by fluorescence in situ hybridization (FISH) negative (not amplified).
· Patient must have progressed (advanced disease therapy) or recurred within ≤12 months (adjuvant therapy) on at least 1 line of ET and 1 cyclin-dependent kinase (CDK)4/6 inhibitor.
· Have the presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (Eisenhauer et al. 2009).
· Have adequate organ function
· Must be able and willing to undergo mandatory tumor biopsy of at least 1 metastatic/advanced disease site, and if clinically feasible, a second mandatory biopsy.
· Not to include primary lesion or target lesions.
· Have a performance status (PS) of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale (Oken et al. 1982).
· Have discontinued previous treatments for cancer (excluding ET) and recovered from the acute effects of therapy.

Criteri di esclusione: 

ND

Trattamento sperimentale: 

LY3295668 (Aurora Kinase Inhibitor)

Trattamento di controllo: 

NA

Centri partecipanti

Nord Italia

Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI

Riferimento: Prof. Giuseppe Curigliano
Telefono: 0257489599
Email: giuseppe.curigliano@ieo.it

 

Centro Italia

Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2018-004183-61

Data di inserimento: 10.01.2020

Promotore

Eli Lilly and Company

CRO

IQVIA

Principal Investigator ITALIA

IEO - Istituto Europeo di Oncologia, Milano

Riferimento: Prof. Giuseppe Curigliano

Telefono: 0257489599

Email: giuseppe.curigliano@ieo.it

Localita: Milano

 

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