The study focuses on early breast cancer, including the subtypes known as TNBC, HER2+, HR+ and HER2‑. Its purpose is to evaluate whether a response‑adapted de‑escalated neoadjuvant approach can achieve a complete disappearance of detectable cancer cells (pCR) and to assess risk‑adapted therapy based on genomic risk categories such as OncotypeDX.
Participants receive a combination of oral and infused medicines that may include ribociclib, tamoxifen citrate, capecitabine, exemestane, letrozole, docetaxel, epirubicin hydrochloride, anastrozole, pembrolizumab, trastuzumab, paclitaxel, pertuzumab, carboplatin, trastuzumab emtansine, abemaciclib and cyclophosphamide monohydrate. Before and after treatment, imaging with MRI and a small tissue sample taken by image‑guided biopsy are used to check for any remaining disease, and a laboratory marker called KI67 is measured to see how the tumor is responding.
The trial begins with screening visits, followed by several cycles of the assigned medicines over a few months, after which surgery is performed. Patients are then monitored regularly for up to several years to record whether the cancer returns, to track overall health and survival, and to collect information on side effects and quality of life using simple questionnaires.
Italy 
