Anlotinib Combined With Chemotherapy and Neoadjuvant Therapy for Hormone Receptor-positive HER-2 Negative Breast Cancer
Status:
Recruiting
Trial end date:
2025-07-30
Target enrollment:
Participant gender:
Summary
Anlotinib is an oral multi-targeted tyrosine kinase inhibitor (TKI) that strongly inhibits
VEGFR, PDGFR, FGFR, and c-kit. Combining anti-angiogenesis with chemotherapy yielded
increased response rates in patients with early-stage human epidermal growth factor receptor
2 (HER2)-negative breast cancer. This study aims to evaluate the efficacy and safety of
adding anlotinib to standard neoadjuvant chemotherapy in primary (HER2)-negative breast
cancer. Patients aged 18 years or older with previously untreated stage ⅡB-IIIA
histologically documented (HER2)-negative breast cancer were assigned to receive chemotherapy
plus oral Anlotinib. The primary endpoint was pathologic complete response (pCR) (no invasive
carcinoma in breast or axilla). Secondary end points included safety and disease-free
survival (DFS).