Novel Neoadjuvant and Adjuvant Strategy for Germline BRCA 1/2 Mutated Triple Negative Breast Cancer

Exclusion Criteria

• •Subjects who has a positive urine pregnancy test within 72 hours prior to registration
• •Has diagnosed as inflammatory breast cancer.
• •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 .
• •Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug.
• •Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
• •Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
• •Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
• •Has severe hypersensitivity (≥Grade 3) to pembrolizumab and investigational drugs used in this study and/or any of their excipients.
• •Has active autoimmune disease that has required systemic treatment in the past 2 years
• •Has a history of (non-infectious) pneumonitis/interstitial lung disease .
• •Has an active infection requiring systemic therapy.
• •Has a known history of Human Immunodeficiency Virus (HIV) infection.
• •Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \[HbsAg\] reactive) or known active Hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection.
• •Has a known history of active TB (Bacillus Tuberculosis).
• •Has a history or current evidence of any condition, therapy, or laboratory abnormality.
• •Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• •Is pregnant or breastfeeding, or expecting to conceive or father children.
• •Has had an allogenic tissue/solid organ transplant.
• •Has received pre-treatment with Olaparib or other PARP inhibitors.
• •Has significant cardiovascular disease
• •Has a resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions.
• •Subject has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
• •Subject received colony-stimulating factors within 28 days prior to the first dose of study intervention.
• •Subject is considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.
• •Is either unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption.
• •Is, in the judgement of the investigator, unlikely to comply with the study procedures, restrictions, and requirements of the study.
• •Is currently receiving either strong or moderate inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study.
• •Is currently receiving either strong or moderate inducers of CYP3A4 that cannot be discontinued for the duration of the study.