Durvalumab With Trastuzumab and Pertuzumab in HER2-Enriched Breast Cancer

Exclusion Criteria

• •1. Participation in another clinical study with an investigational product within 28 days prior to the first dose of study treatment.
• •2. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
• •3. Unresolved or unstable adverse events from prior administration of another investigational drug.
• •4. Any concurrent chemotherapy, radiation therapy, immunotherapy, or biologic therapy for cancer treatment.
• •5. Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of study treatment.
• •6. History of allogenic organ transplantation.
• •7. Active or prior documented autoimmune or inflammatory disorders.
• •8. History of active primary immunodeficiency.
• •9. Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.
• •10. Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment.
• •11. Receipt of live attenuated vaccine within 30 days prior to the first dose of study treatment.
• •12. Patients who are pregnant or breastfeeding or patients of reproductive potential who are not willing to employ effective birth control from screening to 7 months after the last dose of study treatment.
• •13. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
• •14. Patients with a mean QT interval of greater than or equal to 470ms calculated from 3 EKGs
• •15. Patients with underlying cardiovascular conditions that have recently undergone interventions including: cardiac ventricular arrhythmia requiring medication, history of second or third degree AV blocks, myocardial infarction with the previous year, congestive heart failure, and unstable angina
• •16. Patients with a LVEF less than 50%