Phase II Study of SHR-A1811 Alone or With Pyrotinib as Pre-Surgery Treatment in Women With Stage II-III HER2-positive Breast Cancer

What this Trial Is About

Researchers are evaluating the efficacy and safety of SHR-A1811 alone or combined with pyrotinib maleate as a neoadjuvant treatment for female patients with Stage II-III HER2-positive breast cancer. This phase II trial involves patients who have not previously received treatment and aims to assess how well these therapies work before surgery. The study is sponsored by Shengjing Hospital and focuses on improving treatment outcomes for this specific breast cancer type. Participants will receive six cycles of either SHR-A1811 monotherapy or SHR-A1811 combined with pyrotinib maleate. After completing the neoadjuvant therapy, patients will undergo surgery within four weeks. Efficacy assessments will be conducted every two cycles during the treatment period to monitor responses. During the trial, researchers will evaluate the total pathological complete response at the time of surgery, along with other measures such as breast pathological complete response, residual cancer burden, and overall response rate during the 18 weeks of neoadjuvant treatment. Long-term outcomes including overall survival, disease-free survival, and event-free survival will be followed for five years. Participants health-related quality of life will also be monitored throughout the treatment period.

A Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients