Phase I/II clinical trial - Sein métastatique RH+

CT7001_003 (SUMIT ELA)
Sein métastatique RH+
Essai clinique fermé
Public cible
A Phase 1b/2 Open-label Study of Samuraciclib in Combination with Elacestrant in;Participants with Metastatic or Locally Advanced Hormone Receptor-positive and Human;Epidermal Growth Factor Receptor 2-negative Breast Cancer.
Description de l'essai
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.
Investigateur principal