Phase II, multicenter, randomized, open-label study of premenopausal women with luminal breast cancer investigating the effect of oral SERD elacestrant with/without triptorelin in the ER functional pathway and Ki67 proliferation. Preoperative trial – PremiÈRe

Premenopausal women with early luminal breast cancer

Rate of CCCA determined by central assessment by IHC Ki67 (% Ki67 ≤ 2.7%) after short-term elacestrant therapy with or without OFS.

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., Mean change in Ki67 measured by IHC Ki67 expression between pre- and post-treatment samples., Differences in differential expression (mean suppression = 100 - [geometric mean (post treatment / pre-treatment · 100)]) of proliferative genes (BIRC5, CCNB1, CDC20, CDCA1, CEP55, KNTC2, MKI67, PTTG1, RRM2, TYMS and UBE2C)., Proportion of patients switching subtype between pre- and post-treatment samples, 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, Mean change of E2 and FSH levels between pre- and during treatment (D14) and pre-surgery samples, Incidence and severity of adverse events, with severity, determined according to NCI CTAE v.5.0., Change from baseline in targeted clinical laboratory test results, including ECGs

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