BreastVAX: Radiation Boost to Enhance Immune Checkpoint Blockade Therapy

Eligibility Criteria

• * Triple negative breast cancer (TNBC) defined using the ASCO CAP guidelines with the following modification supported by a recent publication as ER ≤ 10%, PR ≤ 10%, HER2- determined by immunohistochemistry and/or fluorescence in situ hybridization analyses and with tumor size ≤ 2.5 cm;
• * HR+ HER2- breast cancer regardless of nodal status and age of diagnosis ≥ 50
• * HR+ HER2- breast cancer and age of diagnosis \<50 with tumor size ≤ 2.5 cm and clinically node (+)
• * HR+ or HR- and HER2+ breast cancer with tumor size ≤ 2.5 cm
• * Ductal carcinoma in situ (DCIS) with microinvasion
• * Locally recurrent breast cancer of any receptor subtype with no prior radiation, not recommended to receive neoadjuvant chemotherapy and expecting surgical excision as part of treatment.
• 1. Not a woman of childbearing potential (WOCBP) as defined in Appendix 2 of the study protocol OR
• 2. A WOCBP who agrees to follow the contraceptive guidance in Appendix 2 during the treatment period and for at least 120 days for study treatments with risk of genotoxicity after the last dose of study treatment.
• * Female participants of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Medically accepted methods of birth control include a diaphragm, cervical cap, latex condoms, surgical sterility, intrauterine devices (IUDs), hormonal implants, injectable contraceptives, or birth control pills. Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year.
• * Ability to tolerate radiation therapy (e.g., lie flat and hold position)
• * Demonstrate adequate hematologic, renal, hepatic, thyroid, and bone marrow function
• * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
• * Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies).
• * 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.