Breast Cancer Clinical Trials

• Female or male patients ≥ 18 years of age.

• Histologically confirmed diagnosis of invasive breast cancer, previously untreated.

• Pre-and postmenopausal women are eligible to participate if not pregnant, not breastfeeding, and at least one of the following conditions applies:

‣ Not a woman of childbearing potential (WOCBP) OR

⁃ A WOCBP who agrees to use effective contraceptive measures that have a failure rate of less than 1% per year from the initiation of treatment through at least 6 months b. after the last dose of study treatment. WOCBP must agree to 1 of the following contraceptive methods:

• Complete abstinence from intercourse of reproductive potential, or

∙ Consistent and correct use of 1 of the following methods of birth control:

⁃ Nonhormonal intrauterine device (IUD); Hormonal IUD in conjunction with a barrier method; Female sterilization (have had surgical bilateral oophorectomy with or; without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment; Vasectomy in the male partner (upon medical assessment of surgical success)

• Male patients with female partners of childbearing potential must practice

‣ Complete abstinence from intercourse of reproductive potential

⁃ Have a surgically successful vasectomy upon medical assessment, or

⁃ Use condoms plus partner use of a contraceptive method with a failure rate of \<1% per year during treatment and until 3 months after last dose of study drug.

• ECOG performance status = 0, 1 (Karnofsky ≥60%, see Appendix A)

• Ability to understand and the willingness to sign a written informed consent form (ICF). Patient has signed the ICF prior to any screening procedures being performed and is able to comply with protocol requirements, including research biopsy.

• Patient has adequate bone marrow and organ function as defined by the following laboratory values at screening:

‣ Absolute neutrophil count (ANC) ≥ 1,500 per mm3

⁃ Platelets ≥ 100,000 per mm3

⁃ Hemoglobin ≥9.0 g/dL

⁃ PT-INR ≤1.5 x institutional ULN unless participant is receiving anticoagulant therapy as long as PT or aPPT is within therapeutic range of intended use of anticoagulants (for patients receiving pembrolizumab only).

⁃ Serum creatinine \<1.5 mg/dL or creatinine clearance ≥50 mL/min (via the Cockcroft-Gault formula) for participants with creatinine levels above institutional upper limit of normal (ULN)

⁃ Adequate hepatic function (bilirubin ≤ 1.5 ULN, AST and ALT ≤ 2.5 X ULN and serum albumin \> 3 g/dL).