Efficacy and Safety of the Proposed Biosimilar Pertuzumab (PERT-IJS) Versus EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Chemotherapy naïve Patients With Early Stage or Locally Advanced HR Negative and HER2 Positive Breast Cancer

Inclusion criteria

• ✓. Patient willing and able to sign informed consent and to follow the protocol requirements
• ✓. Female patients aged ≥ 18 years at the time of Screening
• ✓. Patient with Eastern Cooperative Oncology Group (ECOG) Performance Status \< 2
• ✓. Patients with breast cancer that meets the following criteria:
• ✓. A known case of histologically confirmed invasive breast carcinoma with a primary tumor size of \> 2 cm by standard local assessment technique
• ✓. stage at presentation: early stage (T2-3, N0-1, M0) or locally advanced (T2-3, N2 or N3, M0; T4a-c, any N, M0) or inflammatory (T4d, any N, M0)
• ✓. Patients with HER2 overexpression by Immunohistochemistry (IHC) (defined as IHC 3+, or IHC 2+ with Fluorescence In Situ Hybridization (FISH) confirmation) as per the American Society of Clinical Oncology/College of American Pathologist (ASCO-CAP) guidelines prior to Screening and confirmed centrally before randomization
• ✓. Patients with known HR-ve status (ER-negative and PR-negative) as per local laboratory prior to Screening and confirmed centrally before randomization

Exclusion criteria