Eribulin combined with anlotinib for patients with HER2-negative metastatic breast cancer: A single-arm, multicenter, phase II study.

Eribulin Taxane Clinical endpoint
DOI: 10.1200/jco.2022.40.16_suppl.e13051 Publication Date: 2022-06-06T15:55:46Z
ABSTRACT
e13051 Background: The group of HER2-negative accounts for 70-80% breast cancer and effective treatments heavily pretreated patients with metastatic are urgently needed. Eribulin mesylate is a non-taxane microtubule dynamics inhibitor distinct mode action which can be used as chemotherapeutic agent after failure anthracycline taxanes treatments. Anlotinib novel multitarget tyrosine kinase targeting VEGFR, PDGFR, FGFR, c-Kit. This study aimed to evaluate the efficacy safety combined treatment eribulin anlotinib in (NCT04624711). Methods: open-label, single-arm, phase II enrolled females HER2-neagtive who underwent ≥1 line chemotherapy, including anthracyclines taxanes, cancer. Patients hormone receptor positive have endocrine therapy. All were treated (1.4mg/m2, administered intravenously on Days 1 8 each 21 day cycle) (12mg, qd, orally 1-14 cycle). primary endpoint was progression-free survival (PFS). Secondary endpoints objective response rate (ORR), disease control (DCR), overall (OS) safety. Results: From November 2020 February 2022, 25 this study. Median follow-up 3.45 months (95% CI 3.16-5.06). PFS 4.6 3.55-5.65). Of all whose could evaluated (21/25), no patient achieved complete (CR); 9 (40.91%) 10 (45.45%) got partial (PR) stable (SD), respectively. ORR 40.91% DCR 86.36%. OS has not reached. major treatment-related adverse events (incidence≥10%) neutropenia(48.00%), anemia(37.93%), platelet count decreased (34.48%), fatigue (31.03%), hypoalbuminemia (20.69%), constipation (13.79%), elevated lactate dehydrogenase(13.79%), lymphocyte (10.34%) hypertriglyceridemia (10.34%). most common grade 3/4 neutropenia (20.00%). 16.00% (4/25) had dose reductions. Conclusions: combination showed better tolerable toxicity patients. Further studies enrolling more still Clinical trial information: NCT04624711.
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