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Anlotinib Combined With Chemotherapy and Neoadjuvant Therapy for Hormone Receptor-positive HER-2 Negative Breast Cancer
Sponsor: Xijing Hospital
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
Key Details
Gender
FEMALE
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
31
Start Date
2022-12-05
Completion Date
2028-07-30
Last Updated
2026-06-10
Healthy Volunteers
No
Conditions
Interventions
Anlotinib
Anlotinib (12 mg qd, d1-14; 21 days per cycle; total 5 cycles) Combined TAC×6 cycles: albumin-bound paclitaxel (200mg/m2, 1d Q3W) + pirarubicin (50mg/m2, 1d Q3W) + cyclophosphamide (500mg/m2, 1d Q3W);
Locations (1)
Xijing Hospital Affiliated to Air Force Military Medical University
Xi'an, Shannxi Province, China