Efti in Patients With Hormone Receptor Positive/HER2-neg Breast Cancer

Eftilagimod Alfa (Efti) will be administered subcutaneously at a dose of 30 mg beginning of week 1 of the trial for a total of 3 doses (week 1, 2 and 3). After 3 weeks, efti will be administered starting with week 4, every 2 weeks and combined with either TC or AC

"TC will be administered at docetaxel 75mg/m2 IV and cyclophosphamide 600mg/m2 IV every 3 weeks for a total of 4 administrations starting on week 4 of the trial (weeks 4, 7,10, and 13).~Docetaxel is administered over 60min (dilute in 250 mL NS or D5W to a final concentration of 0.3 to 0.74 mg/mL and administer over 60 minutes).~Cyclophosphamide is administered over 30-60min (dilute in 250 to 500 mL NS or D5W and administer over 30 to 60 minutes after docetaxel).~G-CSF support for TC is per institutional SOC guidelines. Efti is to be given always ≥ 30 minutes after TC is finished if both regimens are administered the same day."

"AC will be administered at doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 IV every 2 weeks for a total of 4 administrations starting week 4 of the trial (weeks 4, 6, 8 and 10):~Doxorubicin is administered over 5 min (Dilute with NS to a final concentration of 2 mg/mL and administered as an IV bolus over three to five minutes into a free flowing IV infusion of NS or D5W).~Cyclophosphamide is administered over 30-60min (Dilute in 250 to 500 mL NS or D5W and administer over 30 to 60 minutes).~G-CSF support is per SOC/institutional guidelines.~Paclitaxel is given weekly for a period of 12 weeks (weeks 12 to 23) at 80mg/m2 (Dilute with 250 to 500 mL NS or D5W (final concentration of 0.3 to 1.2 mg/mL) and administered per institutional guidelines). Alternatively nab-paclitaxel weekly can be used (if paclitaxel cannot be used due to allergic reaction).~Efti is to be given always ≥ 30 minutes after AC or paclitaxel is finished if both regimens are administered the same day."