Clinical trials open for the enrollment


Title: 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”

 

The study was designed to evaluate the efficacy and safety of Datopotamab deruxtecan (Dato-DXd), versus investigator’s choice of chemotherapy (paclitaxel, nab-paclitaxel), in patients with locally relapsed inoperable or metastatic triple-negative breast cancer, ineligible for anti-PD-L1 immunotherapy. This drug belongs to the innovative category of antibody-drug conjugates: specifically, datopotomab (antibody), by binding to TROP2 on tumor cells, allows the penetration of the chemotherapy drug deruxtecan, a topoisomerase I inhibitor.

 

Principal Investigator: Prof. Pierosandro Tagliaferri

 

For enrollment information please contact: Dr. Luigia Gervasi (Tel: +39 0961-3647921) Email: luigiagervasi@gmail.com


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

 

The study investigates the possible role of camizestrant, molecule belonging to the class of SERDs (selective estrogen receptor degraders) after at least 2 years of adjuvant endocrine therapy in ER+/HER2- breast cancer of intermediate or high risk of relapse.

 

Principal Investigator: Prof. Pierfrancesco Tassone

 

For enrollment information please contact: Dr. Luigia Gervasi (Tel: +39 0961-3647921) Email: luigiagervasi@gmail.com


Title: 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”

 

This study offers the opportunity to receive sacituzumab govitecan for who suffers of breast cancer HR+/HER2-, already underwent hormonal therapy, rather than standard chemotherapy.  This molecule is an antibody-drug conjugate: sacituzumab (antibody) binds to TROP2, allowing penetration of SN-38, active methabolite of irinotecan, to penetrate tumor cells.

 

Principal Investigator: Prof. Pierfrancesco Tassone

 

For enrollment information please contact: Dr. Luigia Gervasi (Tel: +39 0961-3647921) Email: luigiagervasi@gmail.com


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

 

Phase 1/2 first-in-human trial that investigates role of BMS-986288 (a modified form of ipilimumab), alone or in association to nivolumab, in various tumors.

 

Principal Investigator: Prof. Pierfrancesco Tassone

 

ENROLLMENT ACTUALLY NOT ACTIVE

 


Clinical trials closed for the enrollment

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

Principal Investigator: Prof. Pierosandro Tagliaferri


Title: 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


Title: 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


Title: 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


Title: 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


Title: 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


Title: 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


Title: 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


Title: 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


Title: 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


Title: 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


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

Principal Investigator: Prof. Pierosandro Tagliaferri


Title: “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


Title: 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


Title: 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


Title: 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


Title: “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


Title: “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


Title: “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


Title: 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


Title: “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