Neoadjuvant Pembrolizumab(Pbr)/Nab-Paclitaxel Followed by Pbr/Epirubicin/Cyclophosphamide in TNBC

Exclusion Criteria

• •1. Concurrent participation in a study with an investigational agent/device or within 14 days of study entry.
• •2. Prior chemotherapy, radiation therapy or small molecule therapy for any reason.
• •3. Previous malignant disease being disease-free for less than 3 years (except in situ carcinoma of the cervix and basal cell carcinoma of the skin).
• •4. Pregnancy or lactation.
• •5. Prior therapy with an anti-PD1, anti-PD L1, anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g. CTLA-4, OX-40, CD137).
• •6. Active infection requiring systemic therapy.
• •7. History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
• •8. Active autoimmune disease or other diseases that requires systemic treatment with corticosteroids or immunosuppressive drugs (physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency is allowed).
• •9. History of primary or acquired immunodeficiency (including allogenic organ transplant).
• •10. Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
• •11. Known history of following infections:
• •1. Human immunodeficiency virus (HIV)
• •2. History of acute or chronic Hepatitis B or Hepatitis C
• •3. Has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted
• •12. Known congestive heart failure \>NYHA I (New York Heart Association) and/or coronary heart disease, angina pectoris, previous history of myocardial infarction, uncontrolled or poorly controlled arterial hypertension (e.g. blood pressure \>160/90 mmHg under treatment with two or more antihypertensive drugs), rhythm disorders with clinically significant valvular heart disease.
• •13. Preexisting motor or sensory neuropathy of a severity grade ≥ 2 by NCI CTCAE v4.0.
• •14. Known, pathogenic BRCA (breast cancer susceptibility gene) mutation. Note: testing is not mandatory for trial participation.
• •15. Any other condition in opinion of the investigator that would interfere with applied systemic treatment or other trial procedures.