Clinical Research Directory

Inclusion Criteria: * Patients will be enrolled in the study if they meet all of the following inclusion criteria: * Age ≥ 18 years * Endocrine sensitivity defined as estrogen and or progesterone receptors expression as per local pathological standards * Her 2 negativity determined as ASCO/CAP guidelines * Patients receiving abemaciclib, olaparib and endocrine therapy, as per Italian drugs agency rules (AIFA) * Written informed consent, signed and dated by the patients * High-risk HR positive, Her2 negative early breast cancer patients with one of the following characteristics: * Anatomical stage IIA N0 with: * Grade 2 and evidence of high risk: * Ki-67 ≥ 20% * Oncotype DX Breast Recurrence Score ≥ 26 or High risk via genomic risk profiling * Grade 3 * Anatomical stage IIB. * Pathological tumour involvement in ≥4 ipsilateral axillary lymph nodes. * Pathological tumour involvement in 1 to 3 ipsilateral axillary lymph node(s) (for patients who received neoadjuvant therapy also cytological tumour involvement at time of initial diagnosis is allowed) and meet at least 1 of the following criteria: * Grade 3 as defined by a combined score of at least 8 points per the modified Bloom-Richardson grading system (Elston and Ellis 1991), * Pathological primary invasive tumour size ≥5 cm (for patients who received neoadjuvant therapy primary tumour size ≥5 cm on breast imaging is allowed). Note: if tumour size is needed to meet eligibility criteria, patients with multifocal/multicentric tumours may be eligible based on the addition of diameters of the individual lesions. BRCA mutated populations Patients must be node positive and fulfil one of the following criteria: * HR positive, HER2-negative patients must have had ≥4 pathologically confirmed positive lymph nodes * patients who received prior neoadjuvant chemotherapy: must have had a CPS\&EG score of ≥3 based on pre-treatment clinical and post-treatment pathologic stage (CPS), estrogen receptor (ER) status and histologic grade Exclusion Criteria: * Patients unable to understand the reason for their participation in the study, lack of informed written consent, * patients who do not meet the high risk criteria as specified in the inclusion criteria, * patients suffering from other neoplasms for which they receive active treatment, or being diagnosed with other neoplasms (except for: Carcinoma in situ (CIS) of the cervix, CIS of the colon, basal cell and squamous cell carcinomas of the skin) in the five years before adjuvant treatment.