...Total bilirubin <1.5 x the institutional ULN Serum creatinine <1.5 x institutional ULN or calculated creatinine clearance ≥45 mL/min Patients from Part 1 who have HER2 overexpression/activation identified by the PRO Onc Assay may enter the treatment portion of Part 2, if they meet all Part 2 eligibility criteria....

...HER2 overexpression or amplification will be based on local test results and is defined as either: (i) IHC staining of 3+ (uniform, intense membrane staining) in greater than or equal to 10% of invasive tumor cells or, (ii) Fluorescent in situ hybridization (FISH) result of more than six HER2 gene copies per nucleus or, (iii) FISH ratio (HER2 gene signals to chromosome 17 signals) of greater than or equal to 2.0....

...Patients ≥ 18 years of age with histologically, and radiographically confirmed non-metastatic ER-positive (defined as ≥30% of positive cells) and HER2-positive (defined as overexpression by immunohistochemistry (3+) or 2+ and positive by defined by fluorescence or dual in situ hybridization.) breast cancer with minimal tumor size over 2 cm (≥T2 lesion) to receive neoadjuvant chemotherapy recommended by the treating physician 2....

...Patients > 18 years of age with HER2-overexpressing early stage breast cancer (Stages I...

...- Overexpression and/or amplification of HER2 in an invasive component of the core biopsy, according to one of the following definitions: •>30% of invasive tumor cells showing strong complete circumferential membrane staining (score 3+) •HER2 gene amplification defined as >6 HER2 gene copies per nucleus by in situ hybridization....

...- Patients must be diagnosed with metastatic cytologically or histologically confirmed adenocarcinoma of the breast with HER2 over-expression or with newly diagnosed locally advanced (including inflammatory) breast cancer (LABC) with stage II-III disease; patients with metastatic (stage IV) disease (MBC) must have measurable lesions...

...The magnitude of antibody levels will be assessed to the vaccine and HER-2 over-expressing cells (e.g.,BT474). ...

Ninety-four women with non-metastatic breast cancer and HER2 overexpression received neoadjuvant combination chemotherapy with Trastuzumab and Pertuzumab at FALP during the period 2017-2020. Seventy percent of patients achieved pCR, and in the group of hormone receptor negative patients, 89% of patients achieved pCR.

A serie of 71 early or locally advanced breast cancer patients with HER2 equivocal overexpression and FISH amplification who received neoadjuvant treatment with chemotherapy and antiHER2 drugs were analyzed their complete pathological response (pCR) and the clinical-pathological variables associated....Patients with equivocal HER2 overexpression and FISH amplification have an overall pCR of only 28.8%. More than 70% have ER positive, and the proportion of pCR is only 17.6%.