This is a pragmatic phase 2 study to determine the proportion of patients with ER+ (≥10%)/HER2- EBC in whom neoadjuvant chemotherapy can be replaced by NET plus abemaciclib based on the results of the ODX RS obtained in the initial diagnostic biopsy and according to the MDT decision and to evaluate the proportion of patients undergoing breast conservative surgery and/or sentinel node biopsy
female aged 18 years or older
primary, histologically confirmed diagnosis of invasive breast carcinoma,
estrogen receptor (ER)-positive tumor, defined as ≥10% by immunohistochemistry and measured as per ASCO/CAP guidelines (Allison et al.2020). Any progesterone receptor expression is acceptable (as per local assessment)
documented human epidermal growth factor receptor-2 (HER2)-negative tumor as per ASCO/CAP guidelines, assessed locally,
presence of distant metastases (stage IV) or stage IIIC disease,
inflammatory or locally-advanced, inoperable breast cancer
previous invasive ipsilateral breast cancer at any time,
basal or squamous cell carcinoma of the skin,
Mario Negri Institute for Pharmacological Research
Lead sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborator
Humanitas Research Hospital IRCCS, Rozzano-Milan
Collaborator
IRCCS San Raffaele
Collaborator
IEO Foundation
Collaborator
Papa Giovanni XXIII Hospital
Collaborator