Adjuvant Treatment Study Comparing Trastuzumab Plus Neratinib Versus Trastuzumab Plus Pertuzumab for Hormone Receptor-Positive, HER2-Positive Breast Cancer with Residual Cancer Burden After Neoadjuvant Therapy

What this Trial Is About

Researchers are evaluating the effectiveness and safety of adding neratinib, an irreversible pan-HER tyrosine kinase inhibitor, to trastuzumab as adjuvant therapy in women with hormone receptor-positive and HER2-positive breast cancer. This study focuses on patients who have residual cancer burden class 0 or I after completing neoadjuvant therapy with trastuzumab and pertuzumab, as there are currently no prospective randomized trials comparing trastuzumab plus pertuzumab versus trastuzumab plus tyrosine kinase inhibitors in this group. Participants will be randomly assigned to receive either trastuzumab combined with pertuzumab or trastuzumab combined with neratinib. Trastuzumab is given intravenously every 3 weeks for a total of 18 cycles covering both preoperative and adjuvant phases. Pertuzumab is administered intravenously with a loading dose followed by maintenance doses every 3 weeks, while neratinib is taken orally daily during the adjuvant period. During the 3 years following random assignment, researchers will monitor invasive disease-free survival as the primary outcome. Secondary outcomes include disease-free survival, overall survival, distant disease-free survival, and the incidence and severity of adverse events. Participants will undergo assessments including echocardiography to monitor heart function and laboratory tests to ensure organ function. The study lasts for several years, with safety and treatment effects closely followed.

Adjuvant Trastuzumab Plus Neratinib in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer After Neoadjuvant Trastuzumab Plus Pertuzumab