BASIC DATA OF THE RESEARCH PROJECT
- ARRS code: J3-3062
- TITLE: Autologous immunohybridomas and advanced treatment of stage II and III triple-negative breast cancer
- PROJECT LEADER: Prof. Matjaž Jeras
- DURATION: 1.10.2021 - 30.9.2024
- APPLICANT RESEARCH ORGANISATION: UNIVERSITY OF LJUBLJANA, FACULTY OF PHARMACY
- PARTICIPATING RESEARCH ORGANISATIONS: Institute of Oncology Ljubljana, CELICA BIOMEDICAL D.O.O.
- FINANCING: Slovenian Research Agency
The study is designed as a phase I / II clinical trial and will be conducted in two parts.
In the first part, for the collection of biological samples, all patients with triple negative breast cancer (TNBC) stages II-III will be included according to the inclusion and exclusion criteria. The second part will include patients with residual tumor after neoadjuvant chemotherapy who will receive experimental treatment with the aHyC vaccine.
The primary endpoints of the clinical study are the feasibility of immune treatment with autologous aHyC cell vaccine after completion of standard triple-negative breast cancer (TNRD) stage II or III and the safety of aHyC immune treatment after completion of standard triple-negative breast cancer (TNRD) or III. Secondary endpoints are the evaluation of immune biomarkers, functional properties of effector CTLs, and the extent of T cell proliferation in blood samples from patients before, during, and after receiving aHy and determination of disease-free survival and overall survival of patients receiving aHyC.
The study will include 30 patients with triple-negative breast cancer, stage II-III, who will be treated with standard neoadjuvant chemotherapy and surgery, and with or without postoperative radiation and adjuvant chemotherapy with capecitabine. The decision on postoperative radiation will be made depending on the initial extent of the disease, the type of surgery and the response to neoadjuvant chemotherapy. However, treatment with capecitabine adjuvant chemotherapy will be performed in those patients who do not achieve a pathological complete response (pCR) with neoadjuvant chemotherapy.