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Endocrine therapy resistance is more common in patients with HR-HER2-Advanced Breast Cancer (ABC), and the dual inhibition of CDK4/6 and PI3K path pathfly can delay the development of drug resistance in such patients.
study was designed to assess the safety and tolerance of triple or dual solutions containing CDK4/6 inhibitor ribociclib.
The study was an open-label, multi-center IB trial that recruited 70 post-menopaus HR-HER2-ABC patients to treat Rebosini (1/day, 3 weeks off for one week) and rybosinib, rebosini (continuous medication) and fluvis, rebosini, alpelisib, fluorovis, or rebosini and buparisib.
phase II dose (RP2D) recommended by Serrabosini was 600 mg (with 3 weeks, suspended for 1 week) and 400 mg (continuous medication), and the combined fluovis group was 500 mg.
for the triple therapy of the combined buparlisib, RP2D is Rebosini 400 mg sbparlisib 30 mg sfluorvis group 500 mg.
triple therapy ended with unexpected toxic effects.
the RP2D of the Alpelisib joint scheme is not clear.
the safety of the joint programmes of Therabosini and Fluvis groups is consistent with previous studies.
there was no significant difference in the exposure of Rebosini in the triple programme group.
the highest overall remission rate (25%) in the Buparlisib triple treatment group.
: Rebosini combined fluorovis group therapy for patients with HR-HER2-ABC is safe.
a triple scenario that includes alpelisib or buparlisib is not recommended for Phase II trials.
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