NCT03580395

Apatinib in Neoadjuvant Therapy for Patients With Breast Cancer

Efficacy and Safety of Apatinib Added to Docetaxel and Cisplatin Neoadjuvant Therapy for Patients With Breast Cancer: a Randomized, Parallel Controlled Phase II Trial

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Hebei Medical University Fourth Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Apatinib	500mg, day1-21,neoadjuvant therapy
DRUG	paclitaxel	paclitaxel 165mg/m2 day 1
DRUG	cisplatin	cisplatin 40mg, day 1-3

Timeline

• Start date: 2017-06-01
• Primary completion: 2022-07-01
• Completion: 2022-12-01
• First posted: 2018-07-09
• Last updated: 2021-07-09

Locations

1 site across 1 country: China