Neoadjuvant Ontruzant (SB3) in Patients With HER2-positive Early Breast Cancer: An Open-Label (NeoON)
Status:
Recruiting
Trial end date:
2023-01-01
Target enrollment:
Participant gender:
Summary
The treatment of patients with HER2 positive early breast cancer has continuously improved
over the last decades. Up to now both, trastuzumab and pertuzumab are approved in combination
with chemotherapy (CTX) not only for the adjuvant but also for the neoadjuvant treatment of
early breast cancer patients. A high pCR rate in the neoadjuvant setting was shown in several
trials and observational studies with CTX+ trastuzumab and with CTX+ pertuzumab. The efficacy
is dependent on a variety of mechanisms including the blocking of the important PI3K/Akt and
MAPK pathways, and ADCC (antibody dependent cellular toxicity).
Recently the biosimilar Ontruzant® (SB3) has been introduced into the treatment of HER2
positive breast cancer as a biosimilar. Efficacy and toxicity have been shown to be
equivalent to the first approved antibody, however, data from the real-world setting have not
been published like it has for the originally approved antibody. Therefore, the aim of this
study is to establish safety and efficacy for Ontruzant® in the real world setting. Patients
can be included if they are treated with Ontruzant® in the neoadjuvant setting. Additionally,
the study will be accompanied by a comprehensive immune monitoring program and biomarker
program to explore immune oncology potential for the neoadjuvant treatment.