Atezolizumab + Stereotactic Radiation in Triple-negative Breast Cancer and Brain Metastasis

Inclusion Criteria

• Participants must have histologically or cytologically confirmed Stage IV invasive breast cancer. Participants without pathologic or cytologic confirmation of metastatic disease should have unequivocal evidence of metastasis from physical examination or radiologic evaluation.
• Either the primary tumor and/or metastatic tumor must be triple-negative as defined below:
• Hormone receptor status: the invasive tumor must be ER- and PR-negative, or staining present in 2.5mg/dL
• serum creatinine ≤1.5mg/dL or calculated GFR ≥60 mL/min
• Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 8 days of initiating protocol therapy.
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of 2mg/day or bioequivalent within 7 days of initiating therapy.
• Patients unable to undergo gadolinium contrast-enhanced MRI or receive IV contrast for any reason (e.g., due to pacemaker, ferromagnetic implants, claustrophobia, extreme obesity, hypersensitity).
• Participants who are receiving any other investigational agents.
• Previous treatment with any anti-PD-1, PD-L1, or PD-L2 agent.
• Subjects with a history of hypersensitivity to compounds of similar biologic composition to atezolizumab or any constituent of the product
• The participant has an uncontrolled intercurrent illness, including, but not limited to uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, congestive heart failure-New York Heart Association Class III or IV, active ischemic heart disease, myocardial infarction within the previous six months, uncontrolled diabetes mellitus, gastric or duodenal ulceration diagnosed within the previous 6 months, severe malnutrition or psychiatric illness/social situations that would limit compliance with study requirements.
• Participant has a medical condition that requires chronic systemic steroid therapy or on any other form of immunosuppressive medication. For example, patients with autoimmune disease that requires systemic steroids or immunosuppression agents should be excluded. Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• Has evidence of active, noninfectious pneumonitis that requires treatment with steroids.
• Has a history of interstitial lung disease.
• The participant is known to be positive for the human immunodeficiency virus (HIV), HepBsAg, or HCV RNA. HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with atezolizumab.
• Individuals with a history of different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years or are deemed by the principal investigator to be at low risk for recurrence of that malignancy.
• Has received a live vaccine within 28 days of planned start of study therapy.
• The participant is pregnant or breast-feeding.