Studi clinici aperti all’arruolamento


Titolo: Tropion-Breast02 – “A Study of Dato-DXd Versus Investigator’s Choice Chemotherapy in Patients With Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer, Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy”

 

Lo studio ha il compito di valutare l’efficacia e la sicurezza di datopotamab deruxtecan (Dato-DXd), rispetto alla chemioterapia a scelta dello sperimentatore (paclitaxel, nab-paclitaxel), in pazienti con carcinoma mammario triplo negativo localmente recidivato inoperabile o metastatico, non eleggibili per immunoterapia anti-PD-L1. Questo farmaco fa parte della innovativa categoria degli anticorpi coniugati: nello specifico, datopotomab (anticorpo), legandosi a TROP2 sulle cellule tumorali, consente la penetrazione del chemioterapico deruxtecan, un inibitore della topoisomerasi I.

 

Principal Investigator: Prof. Pierosandro Tagliaferri

 

Per informazioni sull’arruolamento contattare: Dott.ssa Luigia Gervasi (Tel: 0961-3647921) Email: luigiagervasi@gmail.com


Titolo: CAMBRIA-1 – “A study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy”

 

Lo studio va a indagare il possibile ruolo di camezistrant, molecola appartenente alla classe dei SERD (degradatori selettivi dei recettori degli estrogeni)  dopo almeno 2 anni di terapia endocrina adiuvante nel carcinoma mammario ER+/HER2- a rischio di recidiva intermedio o alto. 

 

Principal Investigator: Prof. Pierfrancesco Tassone

 

Per informazioni sull’arruolamento contattare: Dott.ssa Luigia Gervasi (Tel: 0961-3647921) Email: luigiagervasi@gmail.com


Titolo: ASCENT-07 – “Study of Sacituzumab Govitecan Versus Treatment oh Physician’s Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy”

 

Questo studio offre l’opportunità di ricevere sacituzumab govitecan in chi soffre di carcinoma mammario HR+/HER2-, già sottoposto a terapia ormonale, piuttosto che chemioterapia standard.  Questa molecola è un anticorpo-farmaco coniugato: sacituzumab (anticorpo) si lega a TROP2, consentendo la penetrazione di SN-38, metabolita attivo dell’irinotecan, di penetrare nelle cellule tumorali.

 

Principal Investigator: Prof. Pierfrancesco Tassone

 

Per informazioni sull’arruolamento contattare: Dott.ssa Luigia Gervasi (Tel: 0961-3647921) Email: luigiagervasi@gmail.com


Titolo: CA043-001 – An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers

 

Studio di fase 1/2 first-in-human che indaga il ruolo di BMS-986288 (una forma modificata di ipilimumab), da solo o in associazione a nivolumab, in vari tumori.

 

Principal Investigator: Prof. Pierfrancesco Tassone

 

ARRUOLAMENTO ATTUALMENTE NON ATTIVO

 


Studi clinici chiusi all’arruolamento

Titolo: ROME – “The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy”

Principal Investigator: Prof. Pierosandro Tagliaferri


Titolo: CA209-7FL – “A Randomized, Multicenter, Double-blind, Placebo-controlled Phase 3 Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Patients With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer

Principal Investigator: Prof. Pierfrancesco Tassone


Titolo: CAPITELLO-291 – “A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Fulvestrant Versus Placebo + Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Breast Cancer Following Recurrence or Progression On or After Treatment With an Aromatase Inhibitor”

Principal Investigator: Prof. Pierfrancesco Tassone


Titolo: EL1SSAR – MO39874 – “An Open-Label, Phase IIIb, Single Arm, Multicenter Safety Study of Atezolizumab (Tecentriq) Plus Nab-Paclitaxel in the Treatment of Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer

Principal Investigator: Prof. Pierosandro Tagliaferri


Titolo: MEN1611-01 – “Open-label, Multicentre, Phase Ib Dose-escalation Study of MEN1611, a PI3K Inhibitor Combined With Trastuzumab With or Without Fulvestrant, in Subjects With PIK3CA Mutated HER2 Positive Locally Recurrent Unresectable (Advanced) or Metastatic (a/m) Breast Cancer Progressed to Anti-HER2 Based Therapy”

Principal Investigator: Prof. Pierfrancesco Tassone


Titolo: SERENA-2 – “A Randomised, Open-Label, Parallel-Group, Multicentre Phase 2 Study Comparing the Efficacy and Safety of Oral AZD9833 Versus Fulvestrant in Women With Advanced ER-Positive HER2-Negative Breast Cancer

Principal Investigator: Prof. Pierfrancesco Tassone


Titolo: DS8201-A-U303 – “A Phase 3, Multicenter, Randomized, Open-label, Active Controlled Trial of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC), Versus Treatment of Physician’s Choice for HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects”

Principal Investigator:  Prof. Pierfrancesco Tassone


Titolo: FEVEX- “Fulvestrant Followed by Everolimus Plus Exemestane vs Examestane and Everolimus Followed by Fulvestrant in Postmenopausal Women With HR+ and HER2- Locally Advanced (LABC) or Metastatic Breast Cancer (MBC) Previously Treated With NSAI”

Principal Investigator: Prof. Pierosandro Tagliaferri


Titolo: MARIA- “Non-interventional study to characterize the real world treatment patterns and outcomes of women with ER+, HER2- advanced or metastatic breast cancer in Italy”- A5481031

Principal Investigator: Prof. Pierosandro Tagliaferri


Titolo: APHINITY – “A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer

Principal Investigator: Prof. Pierfrancesco Tassone


Titolo: MARIANNE – “A Randomized, 3 Arm, Multicenter, Phase III Study to Evaluate the Efficacy and the Safety of T-DM1 Combined With Pertuzumab or T-DM1 Combined With Pertuzumab-Placebo (Blinded for Pertuzumab), Versus the Combination of Trastuzumab Plus Taxane, as First Line Treatment in HER2 Positive Progressive or Recurrent Locally Advanced or Metastatic Breast Cancer

Principal Investigator: Prof. Pierfrancesco Tassone


Titolo: REMBRANDT – “Real life Eribulin for Metastatic BReast cANcer DaTabase”

Principal Investigator: Prof. Pierosandro Tagliaferri


Titolo: “A Multicentre, Double Blind, Randomized Placebo Controlled Trial to Assess the Effect of LF-PB on Seroma Formation in Women With Breast Cancer Undergoing Axillary Lymph Node Dissection”

Principal Investigator: Prof. Pierfrancesco Tassone


Titolo: SCHEARLY- “National Phase IIIb Prospective Two-Cohort Non-Randomized, Multi-centre, Open Label Study to Assess the Safety of Subcutaneous Trastuzumab and Molecular Biomarkers in Patients With Early and Locally Advanced HER2-Positive Breast Cancer

Principal Investigator: Prof. Pierfrancesco Tassone


Titolo: NALA – “A study of Neratinib plus Capecitabine versus Lapatinib plus Capecitabine in patients with HER2+ metastatic breast cancer who have received two or more priorHER2-directed regimens in the ,metastatic setting”

Principal Investigator: Prof. Pierfrancesco Tassone


Titolo: ExteNET “A Randomized, Double-Blind, Placebo-Controlled Trial Of Neratinib (HKI-272) After Trastuzumab In Women With Early-Stage HER-2/Neu Overexpressed/Amplified Breast Cancer

Principal Investigator: Prof. Pierfrancesco Tassone


Titolo: “An Open-Label, Randomised Phase 1b/2 Study Of PF-04691502 In Combination With Letrozole Compared With Letrozole Alone In Patients With Estrogen Receptor Positive, Her-2 Negative Early Breast Cancer”

Principal Investigator: Prof. Pierfrancesco Tassone


Titolo: “An Open-Label, Multicenter Extension Study of Trastuzumab Emtansine Administered as a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd-Sponsored Trastuzumab Emtansine Study”

Principal Investigator: Prof. Pierfrancesco Tassone


Titolo: “Studio in aperto, multicentrico, di accesso allargato per donne in post-menopausa con carcinoma mammario positivo per il recettore degli estrogeni localmente avanzato o metastatico che sono progredite a seguito di una precedente terapie endocrina, per studiare il trattamento con everolimus (RAD001) in combinazione con exemestrane”

Principal Investigator: Prof. Pierosandro Tagliaferri


Titolo: BELLE-2 “A Phase III Randomized, Double Blind Placebo Controlled Study of BKM120 With Fulvestrant, in Postmenopausal Women With Hormone Receptor-positive HER2-negative Locally Advanced or Metastatic Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment”

Principal Investigator: Prof. Pierosandro Tagliaferri


Titolo: “A Phase I, Open Label, Parallel Group, Pharmacokinetic Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function”

Principal Investigator: Prof. Pierfrancesco Tassone