Phase I/II clinical trial - Sein métastatique RH+

This is an international, phase 1b/2, multicenter, open-label study conducted in participants with metastatic or locally advanced breast cancer (BC), positive for estrogen receptors and negative for human epidermal growth factor receptor 2 (HER2). Participants must meet all eligibility criteria and maintain the investigational medicinal product (IM) until one of the following events occurs (whichever comes first): objective disease progression, worsening of symptoms , unacceptable, death, withdrawal of consent, investigator's decision to withdraw the participant or sponsor's decision to terminate the study.;Primary objective: Phase 1b (dose determination): determine the recommended dose for phase 2 (DRP2) of the samuraciclib + elacestrant combination.;À Phase 2 (extension): evaluation of the effectiveness of the samuraciclib + elacestrant combination in terms of progression-free survival (PFS) according to the assessment of the local investigator.