Apatinib plus etoposide as second-or higher-line treatment in recurrent or metastatic triple-negative breast cancer: A single-arm, open label, prospective, phase II clinical trial.

e13069 Background: Due to the lack of targeted therapies, the standard of care for advanced triple-negative breast cancer (TNBC) was still chemotherapy, yet its effectiveness remains unsatisfied. Therefore, an urgent need exists to find a novel treatment option for patients with TNBC. The effect and safety profile of apatinib and etoposide have been demonstrated in several clinical trials for the treatment of late-stage TNBC respectively. In the present study, we aimed to investigate the potential effect of combination therapy of apatinib plus etoposide in recurrent or metastatic TNBC. Methods: Patients with late-stage TNBC who failed at least one line of chemotherapy were recruited in our study. Eligible patients were treated with in a 3-week cycle until disease progression or unacceptable toxicity for up to a maximum of 6 cycles. Apatinib could be declined to 250mg according to patients’ condition. Patients who completed their treatment were followed every 8 weeks and their disease progress was assessed scans according to RECIST 1.1. The primary endpoint was progress-free survival (PFS). The secondary endpoints included objective response rate (ORR), disease control rate (DCR), and overall survival (OS). Safety was also evaluated. Results: From August 2018 to September 2021 a total of 40 patients were enrolled in this study. Their median age was 56-year old (range, 27-76) and had received a median of 3 (range, 2-6) previous lines chemotherapy. Until January 2022, among all eligible patients, 30 PFS events were observed. The median PFS was 6 months (95% CI, 3.77̃8.23) and the median OS was 24.53 months (95% CI, 10.23-38.83). Meanwhile, 4 patients achieved partial response, 21 patients achieved stable disease, the ORR was 10% and the DCR was 62.5% In addition, the most common adverse events were hypertension (65%), nausea (47.5%), vomiting (42.5%), and hand–foot syndrome (32.5%). The most common grade ≥ 3 adverse events were hypertension (5%) and proteinuria (5%). Conclusions: The results of the study exhibited a promising clinical effect of the combination therapy of apatinib plus etoposide and acceptable toxicity in recurrent or metastatic TNBC as second-or higher-line treatment. And more results will be updated with the progress of this clinical trial. Clinical trial information: ChiCTR1800018497.