PREMIERE parallel, non-comparative, two-arm, randomized 1:1, open-label, multicenter, exploratory window of opportunity study in premenopausal women with primary operable HR+/HER2-negative breast cancer with aiming at evaluating the biological effects of elacestrant with or without triptorelin.
Signed informed consent must be obtained prior to any trial-specific procedure.
Female patients who are at least 35 years of age on the day of signing informed consent.
Patient is premenopausal at the time of study entry
Patient had last menstrual period within the last 6 months. OR
Inoperable locally advanced or inflammatory breast cancer (any stage III).
Metastatic (Stage IV) breast cancer.
Synchronous invasive bilateral or multicentric breast cancer.
Patients requiring immediate neoadjuvant chemotherapy or immediate surgical intervention.
Parallel
Elacestrant
DrugElacestrant 400 mg given orally on a daily and continuous basis for 30 days or until the day before surgery or biopsy (+7 extra days).
Triptorelin
DrugMonthly triptorelin 3.75 mg powder and solvent for prolonged-release suspension for injection. Each vial contains 3.75 mg of triptorelin (acetate). After reconstitution with 2 ml of solvent, 1 ml of the suspension contains 1.875 mg triptorelin. This drug contains sodium, but less than 1 mmol (23 mg) of sodium per vial.Triptorelin will be administrated on D1 and D29.
Tamoxifen 20 mg
DrugTamoxifen 20 mg given orally on a daily and continuous basis for 30 days or until the day before surgery or biopsy (+7 extra days).
To evaluate the biological activity of elacestrant with or without OFS in premenopausal women with ER+/HER2- operable EBC
Rate of CCCA determined by central assessment by IHC Ki67 (% Ki67 ≤ 2.7%) after 4 weeks of therapy.
To evaluate the biological activity of elacestrant with or without OFS in premenopausal women with ER+/HER2- operable EBC according to baseline research-based PAM50 subtype.
Rate of CCCA determined by central assessment by IHC Ki67 (% Ki67 ≤ 2.7%) after short-term elacestrant therapy with or without OFS for patients Luminal A and Non-Luminal A.
To evaluate the antiproliferative activity of elacestrant with or without OFS after -treatment
Mean change in Ki67 measured by IHC Ki67 expression between pre- and post-treatment samples. - Differences in differential expression of proliferative genes
To identify changes in the research-based PAM50 subtypes pre- and post-treatment samples after treatment
Proportion of patients switching subtype between pre- and post-treatment samples
To evaluate the effect of optimal and suboptimal OFS (E2 level greater than 2.72 pg/mL) in CCCA
Mean change in measured by Ki67 expression between pre- and post-treatment samples and CCCA rate determined by Ki67 ≤ 2.7% between pre- and post-treatment samples of elacestrant therapy with or without OFS
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