Engineered immune cells take on hard-to-treat breast cancer in new trial

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Procurement Inclusion Criteria: 1. Any patient between 18-80 years of age regardless of sex, with a diagnosis of metastatic or locally recurrent unresectable HER2 positive breast cancer. 2. HER2 tumor expression1+, 2+ or 3+ by IHC 3. The disease must have progressed after standard first line therapy. Patients are still eligible if they have failed more than one line of therapy. 4. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent. Treatment Inclusion Criteria: 1. Patients between ages 18 and 80 years old with a diagnosis of either stage IV breast cancer or locally recurrent unresectable breast cancer. Disease must have progressed after standard first line therapy. Patients are still eligible if they have failed more than one line of therapy. 2. Measurable or evaluable disease per RECIST 1.1 criteria. 3. HER2 tumor expression 1+, 2+ or 3+ by IHC. 4. Bilirubin ≤ 3x upper limit of normal. 5. AST and ALT ≤ 3x upper limit of normal 6. Hemoglobin ≥ 7 g/dl (may be transfused values) 7. Serum creatinine \< 2 x the upper limit of normal. 8. Pulse oximetry of \> 90% on room air. 9. Off conventional or investigational therapy for 3 weeks prior to study entry. 10. ECOG Performance Status ≤ 2 11. The patient is able to understand and give informed consent to study related procedures and treatments. Procurement Exclusion Criteria: 1. Known pregnancy or actively breast feeding. 2. Active and uncontrolled bacterial, viral, or fungal infection. 3. Patients with current use of systemic corticosteroids (Prednisone equivalent \>0.5mg/kg/day). 4. Patients with abnormal left ventricular function (LVEF \<55%) 5. Patients with brain metastases that are progressing. Treatment Exclusion Criteria: 1. Pregnant or breast feeding 2. Active and uncontrolled bacterial, viral or fungal infection 3. Patient with current use of systemic corticosteroids (prednisone equivalent \>0.5 mg/kg/day. 4. Patients with abnormal left ventricular function (LVEF \<55%). 5. Patients with brain metastases that are progressing