Neoadjuvant Pembrolizumab and Carboplatin Plus Paclitaxel for Stage I Triple-negative Breast Cancer

Exclusion Criteria

• •1. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
• •2. Has received prior systemic anti-breast cancer therapy, including an investigational agents or has used an investigational device within 4 weeks prior to allocation.
• •3. Has received prior taxane or platinum-based therapy.
• •4. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• •5. Has had an allogenic tissue/solid organ transplant.
• •6. Has a history of invasive malignancy within the last 5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. For other cancers considered to have a low risk of recurrence, discussion with the Medical Monitor is required.
• •7. Participation in an interventional clinical study within 4 weeks of first dose of study treatment.
• •8. Major surgical procedure or significant traumatic injury within 14 days prior to enrolment or anticipation of need for major surgery within the course of the study treatment.
• •9. Has received a live vaccine within 30 days of first dose of study treatment.
• •10. Active autoimmune disease that has required systemic treatment in past 2 years, or ANY diagnosis of immunodeficiency or is receiving systemic steroid therapy (e.g, dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. Replacement therapy (e.g, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
• •11. Current known infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients with past HBV infection or resolved HBV infection (defined as having a negative hepatitis B surface antigen \[HBsAg\] test and a positive hepatitis B core antibody \[HBcAb\] test, accompanied by a negative HBV DNA test) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
• •12. Other active uncontrolled infection at the time of enrollment.
• •13. Significant cardiovascular disease within the last 6 months OR congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV or history of CHF NYHA Class III or IV.
• •14. History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
• •15. Other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, contraindicate patient participation.
• •16. Pregnancy or breastfeeding or expecting to conceive children within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of trial treatment.
• •17. Known hypersensitivity to the components of the study or its analogs.