Comparing Trastuzumab-deruxtecan With Standard Chemotherapy and Antibodies to Improve Neoadjuvant Treatment and Outcomes in HER2-Positive Early Breast Cancer

What this Trial Is About

Researchers are evaluating the best neoadjuvant therapy for patients with less advanced HER2-positive early breast cancer EBC. This Phase 2 trial focuses on improving treatment outcomes by comparing trastuzumab-deruxtecan T-DXd with standard chemotherapy combined with trastuzumab and pertuzumab. The study targets patients with low to intermediate risk HER2 EBC, aiming to show higher rates of complete tumor response and excellent survival outcomes. Participants receive different treatment regimens depending on their risk group and assigned study arm. Treatments include 12 or 18 weeks of T-DXd alone or combined with standard chemotherapy, trastuzumab, and pertuzumab. After neoadjuvant treatment, post-neoadjuvant therapy with T-DXd or standard care continues for up to one year, with adjustments based on tumor response. Some patients may receive additional chemotherapy depending on residual tumor burden. During the study, participants undergo regular evaluations including tumor response assessments and safety monitoring for adverse drug reactions. Key outcomes measured are pathological complete response rate after neoadjuvant therapy and distant disease-free survival after three years. Researchers also track various survival outcomes, quality of life, and treatment-related side effects over time. Participants are followed until study completion in 2030, with detailed monitoring throughout the treatment and follow-up phases.

NeoAdjuvant Therapy With Trastuzumab-deruxtecan Versus Chemotherapy+Trastuzumab+Pertuzumab in HER2+ Early Breast Cancer