Real wOrld studY in the Adjuvant Setting for High Risk earLy Breast Cancer Patients

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.