Fulvestrant and EVerolimus Plus EXemestane in Metastatic Breast Cancer (NCT02404051) | Clinical Trial Compass
UnknownPhase 3
Fulvestrant and EVerolimus Plus EXemestane in Metastatic Breast Cancer
Italy745 participantsStarted 2015-12
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
ā. Adult women (ā„ 18 years of age) with LABC or MBC not amenable to curative treatment by surgery or radiotherapy, refractory to NSAI
ā. Histological or cytological confirmation of ER+ BC and/or PgR+.
ā. Postmenopausal women.
ā. Radiological or objective evidence of recurrence or progression on or after the last systemic therapy prior to randomization
ā. Patients must have:
ā. Adequate bone marrow and coagulation according RCP
ā. Adequate liver function, according RCP
ā. Adequate renal function, according RCP
Exclusion criteria
ā. HER2-overexpressing patients by local laboratory testing (IHC3+ staining or in situ hybridization positive).
ā. Patients who received chemotherapy for MBC
ā. Patients who received more than one NSAI treatment for LABC or MBC
ā. Pre-menopausal, pregnant, lactating women.
ā. Known hypersensitivity to mTOR inhibitors
ā. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption.
What they're measuring
1
Progression-free survival (PFS1)
Timeframe: Time elapsed from randomization to progression or death for any cause whichever occurred first assessed up to 30 months
2
Total Progression-free survival (PFST)
Timeframe: Time elapsed from randomization to progression or death for any cause whichever occurred first assessed up to 30 months