drugset / Trial / NCT03982485

Combination Neoadjuvant Chemotherapy With or Without Apatinib for HER2 Negative Breast Cancer

NCT03982485 ↗

Phase 2 Active not recruiting 196 enrolled RenJi Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

RATIONALE: The combination of anti-angiogenic targeted therapy with neoadjuvant chemotherapy has been shown to further improve the pathologic response rate for HER2-negative breast cancer patients. Apatinib is a highly potent human vascular endothelial growth factor receptor 2 (VEGFR2) tyrosine kinase inhibitor that has been independently developed in China, and it can exert anti-angiogenic effects by inhibiting VEGFR2. It is unknown whether giving combination neoadjuvant chemotherapy together with apatinib is more effective in treating patients with nonmetastatic HER2-negative breast cancer. PURPOSE: To explore the efficacy and safety of apatinib added to weekly paclitaxel and cisplatin neoadjuvant therapy for HER-2 negative breast cancer patients

Timeline

Start
2018-10-16
Primary completion
2023-03-29
Completion
2031-03-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Rivoceranib Small molecule 250 mg Oral
Background Cisplatin Other / unclassified 25 mg/m2 Intravenous
Background Paclitaxel Small molecule 80 mg/m2 Intravenous

Indications