Abstract 118P
Background
Neratinib, an oral irreversible pan-HER tyrosine kinase inhibitor, was approved in 2020 in China based on the ExteNET trial, which is no longer reflective of the current treatment landscape of HER2+ early breast cancer (EBC) in China, with increasing clinical uses of neoadjuvant treatment and recently approved adjuvant anti-HER2 therapies including pertuzumab and trastuzumab emtansine. Thus, there is a need to understand the real-world extended adjuvant neratinib use in China.
Methods
This is a multi-center, prospective, non-interventional study planning to enroll 500 HER2+ EBC patients who scheduled 1 year neratinib treatment after anti-HER2 adjuvant therapy. Pre-specified interim analyses are planned after recruitment of 250 and 500 patients. The primary and secondary objectives are to describe the real-world adjuvant treatment patterns and to observe the safety of patients treated with neratinib respectively. The exploratory objectives are to observe invasive disease recurrence patterns and patient-reported quality of life.
Results
As of 21 September 2023, 250 patients are included in the analysis. The median age of patients was 50.0 years. A total of 161 patients (64.4%) were postmenopausal. At primary diagnosis, 57.2% of the patients had HER2+/hormone receptor positive (HR+) tumors; 24.4% of the patients had cT1 and 57.2% had cT2; 73.6% of patients were N+ and 88.4% had Stage II+ III tumors. A total of 84 patients (33.6%) received neoadjuvant therapy. Fourt-five (53.6%) patients did not achieve a pCR. Trastuzumab plus pertuzumab was the most commonly used neoadjuvant therapy whether the patient achieved pCR or not (97.6% for pCR, 92.3% for non-pCR). A total of 250 patients (100%) received adjuvant treatment, of whom 88% received trastuzumab plus pertuzumab and 10.4% received trastuzumab only.
Conclusions
The results from the NER-Tree study describe the use of the extended adjuvant neratinib in patients with HER2+ EBC that received more recent anti-HER2 therapies including pertuzumab in combination with trastuzumab in China.
Clinical trial identification
NCT05491057.
Legal entity responsible for the study
Pierre Fabre.
Funding
Pierre Fabre.
Disclosure
All authors have declared no conflicts of interest.