NEOadjuvant Abemaciclib and GIredestrant TriaL in Patients with ER-positive, HER2-negative Early Breast Cancer

The objective of the study is to evaluate the efficacy and the safety of abemaciclib and giredestrant before surgery in participants with early stage, oestrogen receptor-positive (ER+), human epidermal receptor 2 negative (HER2-) breast cancer (BC). Primary objective: ● To evaluate the efficacy of abemaciclib and giredestrant in complete cell cycle arrest (CCCA) rate at Week 2. Secondary objectives: * To evaluate the efficacy of abemaciclib and giredestrant in reducing the relative Ki67 expression from baseline to Week 2 * To evaluate the efficacy of abemaciclib and giredestrant in risk of

Trial Details

NCT ID
NCT06259929
Phase
PHASE2
Sponsor
Fondazione Oncotech
Status
RECRUITING
Cancer Type
HER2 Negative Breast Cancer
Interventions
  • Abemaciclib 150 MG + Giredestrant 30 MG
Locations (sample)
  • Catania, Catania, Italy|37.49223,15.07041
  • Genova, Genova, Italy|45.21604,11.87211
  • Naples, Napoli, Italy|40.85216,14.26811
  • Naples, Napoli, Italy|40.85216,14.26811
  • Padova, Padova, Italy|44.38225,11.14261

Key Eligibility Criteria

  • Female patients willing and able to give written informed consent;
  • Women≥18 years of age;
  • Postmenopausal women, as defined by at least one of the following criteria:
  • ≥12 months of amenorrhea without an alternate medical cause plus follicle-stimulating hormone (FSH) and plasma estradiol levels within postmenopaus…

For full eligibility, visit ClinicalTrials.gov.

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