The purpose of the study is to to compare low dose of exemestane (babyexe) versus low dose of tamoxifen (babytam) in terms of change of quality of life from baseline to 12 months.
This is a multicenter, randomized, double blind phase II trial. Eligible patients will be randomized in a 1:1 ratio to: ARM 1: BabyEXE Arm, 25 mg eod, typically every odd day of the monthly calendar for 12 monthsor unless progression, SAE, medical decision, patient withdrawal occur. ARM 2: BabyTAM Arm, 10 mg eod, typically every odd day of the monthly calendar for 12 months or unless progression, SAE, medical decision, patient withdrawal occur. Blinding will be guaranteed by over-encapsulation of active tablet agents with an AA capsule in a 6-month bottle. In both arms, treatment should begin within 30 days from randomization. Exemstane and Tamoxifen will be provided for free by the Study Sponsor. After study completion, participants will be unblinded and treated according to local guidelines. Clinical visit will be performed every 6 months (±14 days) with physical examination vital signs and weight and girth measurement, ECOG PS, MENQOL questionnaire (0, 6, 12 months), review of self-reported compliance, concomitant medications, AEs assessment, and physical exam. Telephone/video contact may be allowed at 3 and 9 months, whereas baseline, 6 months and 12 months visits are necessary for blood collection and biomarker assessment. Blood serum for centralized storage at IEO, Milan, Italy, will be collected at different time points.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
140
Blinded tamoxifen 10 mg every other day
Blinded exemestane 25 mg every other day
E.O. Ospedali Galliera
Genova, Italy, Italy
RECRUITINGQuality of life MEnQol
The primary endpoint is the difference between arms in the score of overall domain of MENQOL after 12 months of treatment.
Time frame: 12 months
Sex hormones
The difference in sex hormones (free estradiol: estradiol/SHBG) and IGF system (IGF-I, IGFBP-3 and their ratio) after 12 months, as surrogate endpoint biomarkers.
Time frame: 12 months
MenQol score domain
The difference between arms in the overall MENQOL score domain after 6 months of treatment.
Time frame: 6 months
Sex hormones
The difference in sex hormones (free estradiol: estradiol/SHBG) and IGF system (IGF-I, IGFBP-3 and their ratio) after 6 months, as surrogate endpoint biomarkers.
Time frame: 6 months
Other domains of MenQol
The difference between arms individual domains of MENQOL (physical, sexual, psychosocial, vasomotor) at 6 and 12 months
Time frame: 6 and 12 months
Safety profile
The difference between arms of safety profile according to CTCAE v.5 at 6 and 12 months.
Time frame: 6 and 12 months
PMAS
The difference between arms at 6 and 12 months in PMAS, Promise Medication Adherence Scale, a validated tool to measure pill adherence.
Time frame: 6 and 12 months
BPI
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The difference between arms on BPI Brief Pain Inventory at 6 and 12 months.
Time frame: 6 and 12 months
Bone biomarker
The difference between arms in C-telopetide at 6 and 12 months
Time frame: 6 and 12 months
Customer satisfatcion
Patient uptake at screening/baseline phase will be measured with a questionnaire including factors related to breast cancer worry and presence of life style risk factors, and participant satisfaction for study explanation.
Time frame: Screening
Exemestane toxicity
Toxicity of babyexe in comparison with full dose historical controls treated in the adjuvant setting will also be evaluated
Time frame: 12 months