Spots Global Cancer Trial Database for Safety and QoL of Trastuzumab With Lapatinib or Chemiotherapy in MBC and HER2+ Patients Refractory to Anti HER2 Therapies
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Trial Identification
Brief Title: Safety and QoL of Trastuzumab With Lapatinib or Chemiotherapy in MBC and HER2+ Patients Refractory to Anti HER2 Therapies
Official Title: A Randomised, Multicentre, Open-label Phase II Trial Investigating Activity of Chemotherapy and Lapatinib and Trastuzumab in Patients With HER2-positive Metastatic Breast Cancer (MBC) Refractory to Anti HER2 Therapies
Study ID: NCT02238509
Conditions
Study Description
Brief Summary: Recent clinical studies have shown that the combination of lapatinib and trastuzumab has superior antitumor activity compared to either single drug in both neoadjuvant and metastatic setting and is well tolerated. According to this evidence, the combination of lapatinib and trastuzumab today offers a valid chemotherapy-free option, primarily for patients with pre-treated HER2-positive MBC
Detailed Description: The present study is designed to determine the efficacy and safety profile of the combination of lapatinib and trastuzumab (plus endocrinetherapy in ER-positive breast cancer) versus trastuzumab and chemotherapy in heavily pretreated patient population with HER2-positive MBC and to investigate the predictive role of cfDNA for detection of HER2 gene amplification on patients' outcome. The presence of circulating free DNA (cfDNA) for detection of HER2 gene amplification was associated with worse prognosis and seems to allow early response evaluation. However, many aspects of the role of cfDNA detection in patients undergoing molecular target agents such as trastuzumab or lapatinib are not well described. With the availability of improved and standardized techniques for cfDNA detection, it should now be possible to examine several of these important questions within a prospective multicenter study and a striking potential of cfDNA for detection of HER2 gene amplification might enable a more individual and optimized antimetastatic therapy inpatients with cancer.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
A.O.U. Ospedali Riuniti Umberto I, Ancona, , Italy
Centro di Riferimento Oncologico, Aviano, , Italy
Policlinico S. Orsola Malpighi, Bologna, , Italy
Ospedale Centrale di Bolzano, Bolzano, , Italy
Presidio Ospedaliero 'Antonio Perrino, Brindisi, , Italy
A.O.R.N.A.S. Garibaldi Nesima di Catania, Catania, , Italy
Humanitas Centro Catanese di Oncologia, Catania, , Italy
Azienda Ospedaliera S. Anna, Como, , Italy
Ospedale 'F. Spaziani', Frosinone, , Italy
I.R.C.C.S. A.O.U. San Martino, Genova, , Italy
Ospedale Civile di Guastalla, Guastalla, , Italy
Ospedale Vito Fazzi, Lecce, , Italy
Ospedale di Lugo - AUSL della Romagna, Lugo, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, , Italy
Ospedale Niguarda Ca' Granda, Milano, , Italy
A.O. San Gerardo, Monza, , Italy
AORN "A. Cardarelli", Naples, , Italy
Istituto Nazionale Tumori - IRCCS "Fondazione G.Pascale", Napoli, , Italy
Policlinico SUN, Napoli, , Italy
Università degli Studi di Napoli "Federico II", Napoli, , Italy
A.R.N.A.S. Ospedale Civico e Benfratelli, Palermo, , Italy
Ospedale S. Maria della Misericordia, Perugia, , Italy
Azienda Ospedaliera Santa Maria degli Angeli, Pordenone, , Italy
Ospedale di Ravenna, Ravenna, , Italy
Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia, Reggio Emilia, , Italy
Ospedale Infermi di Rimini, Rimini, , Italy
Policlinico Universitario Campus Biomedico, Roma, , Italy
Istituto Regina Elena per lo studio e la cura dei tumori, Roma, , Italy
Ospedale G. Da Procida, Salerno, , Italy
Ospedale Civile di Sassari SS Annunaziata, Sassari, , Italy
Ospedale 'SS. Trinità', Sora, , Italy
Azienda Ospedaliera S.Maria di Terni, Terni, , Italy
A.O.U. San Giovanni Battista di Torino, Torino, , Italy
A.O.U. Santa Maria della Misericordia di Udine, Udine, , Italy
A.O. Ospedale di Circolo e Fondazione Macchi, Varese, , Italy
Ospedale Sacro Cuore Don Calabria, Verona, , Italy
Contact Details
Name: Grazia Arpino, MD
Affiliation: Dipartimento di Medicina Clinica e Chirurgia Oncologia Università degli Studi di Napoli "Federico II"
Role: PRINCIPAL_INVESTIGATOR
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