Anlotinib Combined With Chemotherapy and Neoadjuvant Therapy for Hormone Receptor-positive HER-2 Negative Breast Cancer — ACNTBC  

Breast Cancer Stage II Clinical Trial

Official title: Anlotinib Plus Chemotherapy as Neoadjuvant Treatment of High-risk, Early-stage Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer: A Prospective, Single-arm, Single-center, Phase II Clinical Study

Status Recruiting

Clinical Trial 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).

Clinical Trial Description

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 phase II 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 (12 mg qd, d1-14; 21 days per cycle; total 5 cycles). Chemotherapy comprised of pirarubicin at 50 mg/m2 and cyclophosphamide at 500 mg/m2 and albumin-bound paclitaxel at 200 mg/m2, (d1, 21 days per cycle; both total 6 cycles), which was then followed by surgery. 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). Stratification was based on the clinical breast cancer stage . ;

Related Conditions & MeSH terms

• Breast Cancer Stage II
• Breast Neoplasms

• NCT number: NCT05558722
• Study type: Interventional
• Source: Xijing Hospital
• Contact: Ting Wang, PhD
• Phone: 0086-13700283101
• Email: ting_w100@126.com
• Status: Recruiting
• Phase: Phase 2
• Start date: November 30, 2022
• Completion date: July 30, 2025