The purpose of this study is to determine whether exemestane plus everolimus are effective in the treatment of patients who have achieved disease stabilization after induction chemotherapy for hormone-receptor positive metastatic breast cancer.
Postmenopausal women with HR-positive, HER2-negative metastatic breast cancer achieving clinical benefit after the induction chemotherapy for visceral disease with sign(s) and/or symptom(s) will be recruited to receive study the maintenance treatment of everolimus plus exemestane.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Commercially available exemestane was supplied to sites as 25-mg tablets according to local regulations.
Everolimus was administered by continuous oral dosing of two 5-mg tablets or one 10-mg tablets.
Unimed Medical Institute
Hong Kong, China
Progression Free Survival
defined as from date of treatment initiation with everolimus plus exemestane to the date of progression or death if no documented disease progression
Time frame: Every 8 weeks in the first 24 weeks of treatment and every 12 weeks thereafter, up to 8 months (estimated)
Response rate
Time frame: Every 8 weeks, up to 8 months (estimated)
Clinical benefit rate
Time frame: Every 8 weeks, up to 8 months (estimated)
Overall survival
Time frame: date of treatment initiation with everolimus plus exemestane until the date of death, censored at the last date known alive, whichever came first, assessed up to 32 months
Incidence of Adverse Events (AEs)/Serious Adverse Events (SAEs)
Time frame: Continuous during the study, up to 28 days after the last treatment
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