The goal of this interventional study is to determine pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) and Efti treatment. This is a prospective single arm interventional trial in patients with early-stage HR+/HER2 -ve breast cancer (Stage I-III) who are eligible for neoadjuvant chemotherapy (NAC). Enrolled patients will be treated with single agent efti for 3 weeks and then start NAC in combination with efti. There are 2 standard NAC usually used and will be determined by treating physician prior to starting on this trial.
Have histologically documented HR+/HER2 neg (defined as ER expression >10% by IHC and/or PR expression > 10% by IHC and HER2 0 or 1+ or 2+ by IHC or FISH ratio <2 or HER2 gene copy number of <6).
Clinical early-stage breast cancer (Stage I-III) and a candidate for NAC.
Be informed of the investigational nature of the trial and all pertinent aspects of the trial.
Have ECOG performance status of 0-2.
Receiving concurrent anti-neoplastic therapy for another malignancy
Known documented or suspected hypersensitivity to the components of the trial drug or analogs.
Stage IV or patients otherwise not indicated for surgery. Patients with oligometastatic disease who are undergoing curative intent treatment are eligible as long as curative intent surgery is planned.
A woman of child-bearing potential who has a positive serum pregnancy test (within 72 hours) prior to Day 1.
George Washington University
Lead sponsor
Immutep S.A.S.
Collaborator