Spots Global Cancer Trial Database for Fulvestrant and EVerolimus Plus EXemestane in Metastatic Breast Cancer
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Fulvestrant and EVerolimus Plus EXemestane in Metastatic Breast Cancer
Official Title: 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
Study ID: NCT02404051
Study Description
Brief Summary: This is a multi-center, randomized, open-label, parallel group study designed to evaluate efficacy and safety of fulvestrant followed, at progression, by examestane and everolimus versus examestane and everolimus followed, at progression, by fulvestrant in postmenopausal women with HR+ and HER2- LABC or MBC whose disease has progressed to NSAI in the adjuvant or metastatic setting.
Detailed Description: In this study everolimus will be administered in combination with exemestane, which is an irreversible steroidal aromatase inactivator that has demonstrated efficacy in the treatment of postmenopausal patients with ABC. Exemestane is indicated for adjuvant treatment of postmenopausal women with HR+ EBC who have received two to three years of tamoxifen and are switched to exemestane for completion of a total of five consecutive years of adjuvant hormonal therapy. It is also indicated for the treatment of ABC in postmenopausal women whose disease has progressed following tamoxifen therapy (in the USA) or following antiestrogen therapy (in Europe). In 2011, the BOLERO-2 trial reported (5; 33) a significant benefit for HR+ HER2- postmenopausal pretreated women in the ABC setting by combining everolimus with exemestane. In this randomized, double-blind, placebo-controlled trial a statistically significant improvement in PFS by adding everolimus to exemestane versus exemestane alone was reported. Adding everolimus determined a 2.4-fold prolongation in PFS from 3.2 up to 7.4 months and so lowered the risk of cancer progression by 56% for these women. These findings were confirmed by an independent assessment (4.1 vs. 11.0 months, risk reduction: 64%). The QoL data shows positive trend in the everolimus plus exemestane treatment arm.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
ASL19 - Ospedale Cardinal Massaia, Asti, , Italy
Azienda Ospedaliera Policlinico di Bari, Bari, , Italy
Istituto Tumori Giovanni Paolo II, Bari, , Italy
Azienda Ospedaliera "G. Rummo", Benevento, , Italy
Ospedale Fatebenefratelli 'Sacro Cuore di Gesù' di Benevento, Benevento, , Italy
A.O. Ospedale Papa Giovanni XXIII, Bergamo, , Italy
Presidio Ospedaliero Antonio Perrino, Brindisi, , Italy
Azienda Ospedaliera - A. Businco - A.S.L. N. 8, Cagliari, , Italy
Fondazione del Piemonte per l' Oncologia - Istituto di Ricovero e Cura a Carattere Scientifico (I.R.C.C.S.), Candiolo, , Italy
ASL di Taranto - Polo Occidentale, Castellaneta, , Italy
A.O.R.N.A.S. Garibaldi Nesima di Catania, Catania, , Italy
Fondazione per la Ricerca e la Cura dei Tumori T. Campanella - Campus S. Venuta, Catanzaro, , Italy
Azienda Ospedaliera S. Croce e Carle, Cuneo, , Italy
Ospedale Infermi di Rimini, Faenza, , Italy
Azienda Ospedaliera Universitaria Careggi, Firenze, , Italy
Azienda Ospedaliero - Universitaria Ospedali Riuniti di Foggia, Foggia, , Italy
I.R.C.C.S. A.O.U San Martino - IST, Genova, , Italy
Ospedale Civile di guastalla, Guastalla, , Italy
Ospedale Civile San Salvatore - Università degli Studi L'Aquila, L'Aquila, , Italy
Presidio Ospedaliero "Renzetti", Lanciano, , Italy
Ospedale Vito Fazzi, Lecce, , Italy
Ospedale di Macerata, Macerata, , Italy
AO Papardo, Messina, , Italy
AORN . Ospedali dei colli Monaldi-Cotugno, Napoli, , Italy
Azienda Ospedaliera 'A. Cardarelli' (AORN), Napoli, , Italy
Azienda Ospedaliera Universitaria Federico II, Napoli, , Italy
Istituto Nazionale per lo studio dei Tumori - Fondazione 'Pascale', Napoli, , Italy
A.O.U. 'Maggiore della Carità', Novara, , Italy
A.O.U.P. 'Paolo Giaccone', Palermo, , Italy
Azienda Ospedaliera S. Chiara, Pisa, , Italy
Ospedale F. Lotti, Pontedera, , Italy
Ospedale di Ravenna, Ravenna, , Italy
Campus Biomedico di Roma, Roma, , Italy
Istituto Regina Elena per lo studio e la cura dei tumori - Oncologia A, Roma, , Italy
Istituto Regina Elena per lo studio e la cura dei tumori - Oncologia B, Roma, , Italy
Azienda Ospedaliera 'San Giovanni di Dio e Ruggi D'Aragona', Salerno, , Italy
IRCCS - Istituto di Ricovero e Cura a Carattere Scientifico 'Casa Sollievo della Sofferenza', San Giovanni rotondo, , Italy
Azienda Ospedaliera Universitaria di Sassari, Sassari, , Italy
Azienda Ospedaliero Universitaria ´S. Maria della Misericordia´ di Udine, Udine, , Italy
"Ospedale Borgo Roma Verona Sezione di Oncologia Medica", Verona, , Italy
Ospedale Sacro Cuore Don Calabria di Negrar, Verona, , Italy
Contact Details
Name: Sabino De Placido, MD
Affiliation: Dipartimento di Medicina Clinica e Chirurgia Oncologia Università degli Studi di Napoli "Federico II"
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
