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Published on: August 19, 2025
Multicenter phase II study of apatinib in non-triple-negative metastatic breast cancer
Xichun Hu1, Jun Cao, Wenwei Hu
1Department of Medical Oncology, Fudan University Cancer Hospital, Shanghai Medical School, Shanghai, China. huxicun@gmail.com.
Background:
Apatinib is a tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor 2(VEGFR-2). This study was conducted to assess the efficacy and safety of apatinib in patients with non-triple-negative metastatic breast cancer who had received prior chemotherapy for their metastatic disease.
Methods:
This multicenter, open-label, single arm study enrolled patients with non-triple-negative breast cancer, pretreated with anthracycline, taxanes and capecitabine, and who failed in the metastatic setting at least 1 and at most 4 prior chemotherapy regimens and at least one endocrine drug for hormone receptor-positive patients as well as at least one anti-Her2 drug for Her2-positive patients. The primary end point of this study was progression free survival (PFS). Secondary end points included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and toxicity. Apatinib was administered as 500 mg daily on days 1 through 28 of each 4-week cycle.
Results:
38 patients were enrolled with a median age of 49 years (range, 35 to 62 years) and received apatinib for a median of 4 cycles (range from 0 to 10 cycles). 18 (47.4%) patients experienced dose reduction during treatment. The median relative dose intensity (relative to assigned dose for each cycle) was 82% (range, 45.0% to 100.0%). Median follow-up time was 10.1 months. Median PFS of all 38 patients was 4.0 months (95% confidence interval (CI), 2.8 m - 5.2 m). 36 patients were eligible for efficacy analysis. ORR was 16.7% (6/36). DCR was 66.7% (24/36). Median OS was 10.3 months (95% CI, 9.1 m - 11.6 m). The most common grade 3/4 treatment-related AEs were hypertension (20.5%), hand-foot syndrome (10.3%), and proteinuria (5.1%). Of three possibly drug-related SAEs recorded in the study, 2 (3.4%) deaths occurred within 28 days of last treatment and were both considered to be the result of disease progression. The other one was grade 2 diarrhea needing hospitalization.
Conclusions:
Apatinib exhibited objective efficacy in heavily pretreated, metastatic non-triple-negative breast cancer with manageable toxicity, and it might be better to be tested in breast cancer with high angiogenesis dependency.
Trial Registration:
ClinicalTrials.gov: NCT01653561.
Insights
Apatinib showed efficacy in heavily pretreated metastatic non-triple-negative breast cancer, demonstrating a median progression-free survival of 4.0 months. The treatment was associated with manageable toxicities, including hypertension and hand-foot syndrome.
Area of Science:
- Oncology
- Pharmacology
Background:
- Apatinib targets vascular endothelial growth factor receptor 2 (VEGFR-2), a tyrosine kinase inhibitor.
- This study evaluated apatinib in patients with non-triple-negative metastatic breast cancer previously treated with chemotherapy.
Purpose of the Study:
- To assess the efficacy and safety of apatinib in a specific patient population.
- To determine progression-free survival (PFS) as the primary endpoint.
Main Methods:
- A multicenter, open-label, single-arm study enrolled 38 patients.
- Patients had non-triple-negative breast cancer, pretreated with anthracyclines, taxanes, capecitabine, and failed at least one prior chemotherapy regimen.
- Apatinib was administered at 500 mg daily for 28-day cycles.
Main Results:
- Median PFS was 4.0 months (95% CI, 2.8-5.2 m) in 36 evaluable patients.
- Objective response rate (ORR) was 16.7% and disease control rate (DCR) was 66.7%.
- Common grade 3/4 adverse events included hypertension (20.5%) and hand-foot syndrome (10.3%).
Conclusions:
- Apatinib demonstrated objective efficacy in heavily pretreated metastatic non-triple-negative breast cancer.
- The toxicity profile was manageable.
- Further investigation in breast cancer with high angiogenesis dependency may be warranted.
