Fulvestrant and EVerolimus Plus EXemestane in Metastatic Breast Cancer (FEVEX)
Metastatic Breast Cancer, Breast Cancer, Hormone Receptor Positive Tumor
About this trial
This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring Breast cancer, HER2Negative, hormone receptor positive (HR+), Metastatic, Locally Advanced, fulvestrant, everolimus, exemestane
Eligibility Criteria
Inclusion Criteria:
- Adult women (≥ 18 years of age) with LABC or MBC not amenable to curative treatment by surgery or radiotherapy, refractory to NSAI
- Histological or cytological confirmation of ER+ BC and/or PgR+.
- Postmenopausal women.
- Radiological or objective evidence of recurrence or progression on or after the last systemic therapy prior to randomization
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.
- Adequate bone marrow and coagulation according RCP
- Adequate liver function, according RCP
- Adequate renal function, according RCP
- ECOG Performance Status ≤ 2
- Written informed consent
Exclusion Criteria:
- HER2-overexpressing patients by local laboratory testing (IHC3+ staining or in situ hybridization positive).
- Patients who received chemotherapy for MBC
- Patients who received more than one NSAI treatment for LABC or MBC
- Pre-menopausal, pregnant, lactating women.
- Known hypersensitivity to mTOR inhibitors
- Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption.
- Radiotherapy within four weeks prior to enrollment
- Currently receiving hormone replacement therapy, unless discontinued prior to enrollment.
- Patients receiving concomitant immunosuppressive agents or chronic corticosteroids use, at the time of study entry except in some cases
- Patients with symptomatic visceral disease in need of urgent disease control
- Symptomatic brain or other CNS metastases.
- Patients with a known history of HIV seropositivity.
- Active, bleeding diathesis, or on oral anti-vitamin K medication (except cases).
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.
Hepatic-related exclusion criteria:
- 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
- Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A
- History of non-compliance to medical regimens.
- 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
Sites / Locations
- ASL19 - Ospedale Cardinal MassaiaRecruiting
- Azienda Ospedaliera Policlinico di Bari
- Istituto Tumori Giovanni Paolo II
- Azienda Ospedaliera "G. Rummo"
- Ospedale Fatebenefratelli 'Sacro Cuore di Gesù' di Benevento
- A.O. Ospedale Papa Giovanni XXIIIRecruiting
- Presidio Ospedaliero Antonio PerrinoRecruiting
- Azienda Ospedaliera - A. Businco - A.S.L. N. 8
- Fondazione del Piemonte per l' Oncologia - Istituto di Ricovero e Cura a Carattere Scientifico (I.R.C.C.S.)Recruiting
- ASL di Taranto - Polo Occidentale
- A.O.R.N.A.S. Garibaldi Nesima di CataniaRecruiting
- Fondazione per la Ricerca e la Cura dei Tumori T. Campanella - Campus S. Venuta
- Azienda Ospedaliera S. Croce e CarleRecruiting
- Ospedale Infermi di RiminiRecruiting
- Azienda Ospedaliera Universitaria Careggi
- Azienda Ospedaliero - Universitaria Ospedali Riuniti di Foggia
- I.R.C.C.S. A.O.U San Martino - ISTRecruiting
- Ospedale Civile di guastallaRecruiting
- Ospedale Civile San Salvatore - Università degli Studi L'Aquila
- Presidio Ospedaliero "Renzetti"Recruiting
- Ospedale Vito FazziRecruiting
- Ospedale di Macerata
- AO PapardoRecruiting
- AORN . Ospedali dei colli Monaldi-CotugnoRecruiting
- Azienda Ospedaliera 'A. Cardarelli' (AORN)Recruiting
- Azienda Ospedaliera Universitaria Federico IIRecruiting
- Istituto Nazionale per lo studio dei Tumori - Fondazione 'Pascale'Recruiting
- A.O.U. 'Maggiore della Carità'Recruiting
- A.O.U.P. 'Paolo Giaccone'Recruiting
- Azienda Ospedaliera S. ChiaraRecruiting
- Ospedale F. LottiRecruiting
- Ospedale di RavennaRecruiting
- Campus Biomedico di RomaRecruiting
- Istituto Regina Elena per lo studio e la cura dei tumori - Oncologia ARecruiting
- Istituto Regina Elena per lo studio e la cura dei tumori - Oncologia BRecruiting
- Azienda Ospedaliera 'San Giovanni di Dio e Ruggi D'Aragona'Recruiting
- IRCCS - Istituto di Ricovero e Cura a Carattere Scientifico 'Casa Sollievo della Sofferenza'Recruiting
- Azienda Ospedaliera Universitaria di Sassari
- Azienda Ospedaliero Universitaria ´S. Maria della Misericordia´ di Udine
- "Ospedale Borgo Roma Verona Sezione di Oncologia Medica"Recruiting
- Ospedale Sacro Cuore Don Calabria di NegrarRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
ARM 1
ARM 2
Everolimus plus Exemestane -> progression disease (PD) -> fulvestrant (ARM 1)
Fulvestrant -> progression disease (PD) -> everolimus plus exemestane (ARM 2)