Pharmacogenomic Study of Neoadjuvant Eribulin for HER2 Non-overexpressing Breast Cancer

Inclusion Criteria: * Written informed consent, specifically highlighting the molecular characterization of tumor and genomic samples * Age ≥18 years * Histologically confirmed invasive breast carcinoma, with all of the following characteristics: * Primary tumor ≥2cm in largest diameter (cT1-3) * cN0-1 * No evidence of distant metastasis (M0) * Breast cancer (BC) eligible for primary surgery * Available pre-treatment core (Tru-cut) biopsy or possibility of performing one * HER2-negative BC (as per local assessment), defined as either of the following: * 0-1+ expression by IHC * 2+ expression by IHC and in situ hybridization (FISH/CISH) without HER2 gene amplification (\<4 HER2 gene copies per nucleus, or a FISH ratio \[HER2 gene copies to Cr17 signals\] of \<1.8) * Is situ hybridization (FISH/CISH) without HER2 gene amplification, independently of IHC * Known hormone receptor (ER/PgR) status (as per local assessment) or the possibility of performing the tests * Known percentage of hormone receptor (ER/PgR) and Ki67-positive tumor cells (as per local assessment), or possibility of performing the tests * In the case of a multifocal tumor, the largest lesion must be ≥2 cm and designated the "target" lesion for all subsequent tumor evaluations and HER2-negative status must be documented in all the tumor foci * ECOG performance status of 0 or 1 * Laboratory values as follows: * Absolute neutrophil count (ANC) ≥1.5 x 109/L * Platelets count ≥100 x 109/L * Hemoglobin ≥9 g/dL * Serum bilirubin ≤1.5 time the upper limit of normal (ULN) * Alanine aminotransferase and aspartate aminotransferase (AST) ≤2.5 x ULN * Alkaline phosphatase ≤2.5 x ULN * Serum creatinine ≤1.5 mg/dL or calculated creatinine clearance ≥60 mL/m * Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * Ability and willingness to comply with study visits, treatment, testing, and to comply with the protocol * Availability of genomic DNA (via whole blood) Exclusion Criteria: * Any prior treatment for primary invasive BC * Metastatic, locally advanced or inflammatory (i.e., Stage III-IV) BC * Bilateral invasive BC * Multicentric BC, defined as the presence of two or more foci of cancer in different quadrants of the same breast * Pre-existing peripheral neuropathy of any grade * Uncontrolled hypertension (systolic \>150 mmHg and/or diastolic \>100 mmHg) * Clinically significant (i.e., active) cardiovascular disease * Long QT syndrome * Concomitant use of inhibitors of hepatic transport proteins such as organic anion-transporting proteins, P-glycoprotein, multidrug resistant proteins etc * Major medical conditions that might affect study participation (e.g., uncontrolled seizure disorder, uncontrolled pulmonary, renal or hepatic dysfunction, or uncontrolled infection) * Other primary malignant tumors within the previous 5 years, except for adequately controlled limited basal cell carcinoma of the skin or carcinoma in situ of the cervix * Known human immunodeficiency virus(HIV) infection or other active or serious infection requiring IV antibiotics at randomization * Pregnancy or breastfeeding women * Women of childbearing potential(\<2 years after the last menstruation) not using effective, non-hormonal means of contraception during the study and for a period of 6 months following the last administration of study drug * Administration of any live virus vaccine within 8 weeks preceding study entry * Use of any investigational agent within 30 days of administration of the first dose of study drug or concurrent treatment on another clinical study * Requirement for radiation therapy concurrent with study anticancer treatment * Known hypersensitivity to any of the study drugs or excipients * Inability or unwillingness to abide by the study protocol or cooperate fully with the investigator or designee