Fulvestrant and EVerolimus Plus EXemestane in Metastatic Breast Cancer
NCT ID: NCT02404051
Last Updated: 2016-06-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
745 participants
INTERVENTIONAL
2015-12-31
2019-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ARM 1
Everolimus plus Exemestane -\> progression disease (PD) -\> fulvestrant (ARM 1)
Everolimus
10 mg daily tablets
Exemestane
25 mg daily tablets
Fulvestrant
500 mg i.m. on Days 1, 15 and 29 and every 28 days thereafter
ARM 2
Fulvestrant -\> progression disease (PD) -\> everolimus plus exemestane (ARM 2)
Everolimus
10 mg daily tablets
Exemestane
25 mg daily tablets
Fulvestrant
500 mg i.m. on Days 1, 15 and 29 and every 28 days thereafter
Interventions
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Everolimus
10 mg daily tablets
Exemestane
25 mg daily tablets
Fulvestrant
500 mg i.m. on Days 1, 15 and 29 and every 28 days thereafter
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histological or cytological confirmation of ER+ BC and/or PgR+.
3. Postmenopausal women.
4. Radiological or objective evidence of recurrence or progression on or after the last systemic therapy prior to randomization
5. Patients must have:
* At least one lesion that can be accurately measured in at least one dimension ≥ 20 mm with conventional imaging techniques or ≥ 10 mm with spiral CT or MRI
* Bone lesions: lytic or mixed (lytic + sclerotic) in the absence of measurable disease as defined above.
6. Adequate bone marrow and coagulation according RCP
7. Adequate liver function, according RCP
8. Adequate renal function, according RCP
9. ECOG Performance Status ≤ 2
10. Written informed consent
Exclusion Criteria
2. Patients who received chemotherapy for MBC
3. Patients who received more than one NSAI treatment for LABC or MBC
4. Pre-menopausal, pregnant, lactating women.
5. Known hypersensitivity to mTOR inhibitors
6. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption.
7. Radiotherapy within four weeks prior to enrollment
8. Currently receiving hormone replacement therapy, unless discontinued prior to enrollment.
9. Patients receiving concomitant immunosuppressive agents or chronic corticosteroids use, at the time of study entry except in some cases
10. Patients with symptomatic visceral disease in need of urgent disease control
11. Symptomatic brain or other CNS metastases.
12. Patients with a known history of HIV seropositivity.
13. Active, bleeding diathesis, or on oral anti-vitamin K medication (except cases).
14. Any severe and / or uncontrolled medical conditions such as:
* Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤6 months prior to enrollment, serious uncontrolled cardiac arrhythmia
* Uncontrolled diabetes as defined by fasting serum glucose \> 1.5 × ULN
* Acute and chronic, active infectious disorders
* Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of the study treatments (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome)
* Inability to swallow oral medications
* Significant symptomatic deterioration of lung function.
* History of liver disease, such as cirrhosis or chronic active hepatitis B and C.
* Presence of Hepatitis B surface antigen (HbsAg) and/or of Hepatitis B Virus - Deoxyribonucleic acid (HBV-DNA)
* Presence of anti-HCV and/or HCV-RNA-PCR
* History of, or current alcohol misuse/abuse within the past 12 months
* Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A within the last 5 days prior to enrollment.
* History of non-compliance to medical regimens.
* Patients unwilling to or unable to comply with the protocol
16. Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A
17. History of non-compliance to medical regimens.
18. Patients unwilling to or unable to comply with the protocol.
Screening for hepatitis B
Prior to enrollment, peculiar patients should be tested for hepatitis B viral load and serologic markers, that is, HBV-DNA, HBsAg, HBsAb, and HBcAb:
Screening for hepatitis C Patients with any of the following risk factors for hepatitis C should be tested
18 Years
FEMALE
No
Sponsors
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Clinical Research Technology S.r.l.
INDUSTRY
Consorzio Oncotech
OTHER
Responsible Party
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Principal Investigators
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Sabino De Placido, MD
Role: PRINCIPAL_INVESTIGATOR
Dipartimento di Medicina Clinica e Chirurgia Oncologia Università degli Studi di Napoli "Federico II"
Locations
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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
Florence, , 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
Presidio Ospedaliero "Renzetti"
Lanciano, , Italy
Ospedale Vito Fazzi
Lecce, , Italy
Ospedale Civile San Salvatore - Università degli Studi L'Aquila
L’Aquila, , 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
Countries
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Central Contacts
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Clinical Research Technology
Role: CONTACT
Other Identifiers
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2014-004035-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GIM16-FEVEX
Identifier Type: -
Identifier Source: org_study_id
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