OncRef

Clinical Trial: NCT05558722

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 2

Lead Sponsor:Xijing Hospital
Information Provided By:Xijing Hospital
Last Update Posted:2026-06-10

Study Overview

Brief 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 Ⅱ-III 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 event-free survival (EFS).

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

Conditions

Breast Cancer Stage II

Intervention / Treatment

  • Drug: Anlotinib

Other Study ID Numbers

  • KY20202075-F-2

Start Date (Actual)

2022-12-05

Primary Completion Date (Actual)

2024-08-15

Study Completion Date (Estimated)

2028-07-30

Enrollment (Actual)

31

Study Type

Interventional

Phase

Phase 2