drugset / Trial / NCT03580395

Apatinib in Neoadjuvant Therapy for Patients With Breast Cancer

NCT03580395

Phase 2/3 Unknown 200 enrolled Hebei Medical University Fourth Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

To verify the role of apatinib in neoadjuvant therapy for breast cancer, the investigators designed a prospective, randomized, parallel-controlled phase II/III trial, to investigate the efficacy and safety of apatinib combined with TP (paclitaxel + cisplatin) or TP regimen alone as neoadjuvant therapy for stage II-III breast cancer treatment. 100 cases of eligible patients were diagnosed by core needle biopsy and immunohistochemistry, with the molecular subtypes of triple-negative, HER2+ or Luminal B, evaluated by pathological complete remission (pCR), objective response rate (ORR), adverse events, disease free survival (DFS) and OS, aiming at providing a new way for neoadjuvant therapy in breast cancer and anti-angiogenic treatment of malignant tumors.

Timeline

Start
2017-06-01
Primary completion
2022-07
Completion
2022-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Rivoceranib Small molecule 500 mg
Background Cisplatin Other / unclassified 40 mg
Background Paclitaxel Small molecule 165 mg/m2

Indications