A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer

Exclusion Criteria

• •Stage IV (metastatic) breast cancer
• •Patients with a history of invasive breast cancer
• •Patients with a history of concurrent or previously treated non-breast malignancies except for appropriately treated 1) non-melanoma skin cancer and/or 2) in situ carcinomas, including cervix, colon, and skin
• •Patients who have received any previous systemic therapy for treatment or prevention of breast cancer, or radiation therapy for treatment of cancer
• •Patients who have a past history of ductal carcinoma in situ or lobular carcinoma in situ if they have received any systemic therapy for its treatment or radiation therapy to the ipsilateral breast
• •Patients with high-risk for breast cancer who have received chemo-preventative drugs in the past are not allowed to enter the study
• •Patients with multicentric breast cancer, unless all tumors are HER2-positive
• •Patients with bilateral breast cancer
• •Patients who have undergone an excisional biopsy of primary tumor and/or axillary lymph nodes
• •Axillary lymph node dissection prior to initiation of neoadjuvant therapy
• •Sentinel lymph node biopsy prior to neoadjuvant therapy
• •Treatment with any investigational drug within 28 days prior to randomization
• •Serious cardiac illness or medical conditions
• •Inadequate bone marrow function, renal function or impaired liver function
• •Current severe, uncontrolled systemic disease that may interfere with planned treatment
• •Pregnant or breastfeeding, or intending to become pregnant during the study or within 7 months after the last dose of HER2-targeted therapy
• •Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
• •Known active liver disease, for example, active viral hepatitis infection, autoimmune hepatic disorders, or sclerosing cholangitis
• •Concurrent, serious, uncontrolled infections, or known infection with HIV
• •Known hypersensitivity to study drugs, excipients, and/or murine proteins
• •Current chronic daily treatment with corticosteroids
• •History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, colon, skin, and/or non-melanoma skin carcinoma
• •History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias, such as structural heart disease, coronary heart disease, clinically significant electrolyte abnormalities, or family history of sudden unexplained death or long QT syndrome