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Combination Neoadjuvant Chemotherapy With or Without Apatinib for HER2 Negative Breast Cancer
Sponsor: RenJi Hospital
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
Official title: Neoadjuvant Apatinib Added to Weekly Paclitaxel and Cisplatin in Patient With Locally Advanced or Early Stage HER2 Negative Breast Cancer (APP) : a Open-label, Randomized, Controlled, Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
196
Start Date
2018-10-16
Completion Date
2031-03-29
Last Updated
2024-04-30
Healthy Volunteers
No
Conditions
Interventions
Apatinib
Apatinib 250mg, Oral, day 2,3,4,5,6,7, every week
Paclitaxel
Paclitaxel 80mg/m2, Intravenous, day 1, 8, 15, 22, every 28 days for a cycle
Cisplatin
Cisplatin 25mg/m2, Intravenous, day 1, 8, 15, every 28 days for a cycle
Surgery
Surgery
Locations (1)
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China