NCT05483439

A Study of Immunotherapy Combined With Neoadjuvant Therapy Versus Neoadjuvant Therapy for Breast Cancer

Clinical Study Comparing the Efficacy and Safety of Traditional Herbal Medicine for Cancer Immunotherapy Combined With Neoadjuvant Therapy Versus Neoadjuvant Therapy in Patients With Stage II-III Breast Cancer.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Shengjing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open label Phase II neoadjuvant study comparing the efficacy and safety of the combination of traditional herbal medicine for cancer immunotherapy and neoadjuvant therapy versus neoadjuvant therapy in patients with breast cancer.

Detailed description

This is a randomized, open label Phase II neoadjuvant study comparing the efficacy and safety of the combination of traditional herbal medicine for cancer immunotherapy and neoadjuvant therapy versus neoadjuvant therapy in patients with breast cancer. Patients will be randomized (1:1) to one of the two treatment arms: arm 1, combination of traditional herbal medicine for cancer immunotherapy and neoadjuvant therapy for 6 or 8 cycles; arm 2, neoadjuvant therapy 6 or 8 cycles. Patients will undergo surgery after neoadjuvant therapy. Efficacy will be assessed every 2 cycles.

Conditions

• Stage II-III Breast Cancer

Interventions

Type	Name	Description
DRUG	cytotoxic chemotherapy (docetaxel or epirubicin or cyclophosphamide or carboplatin)	Drug: cytotoxic chemotherapy (docetaxel or epirubicin or cyclophosphamide or carboplatin)
DRUG	anti-Her2 monoclonal antibody (Trastuzumab, Pertuzumab)	anti-Her2 monoclonal antibody (Trastuzumab, Pertuzumab)
DRUG	traditional herbal medicine	traditional herbal medicine

Timeline

• Start date: 2021-10-20
• Primary completion: 2023-07-01
• Completion: 2023-07-01
• First posted: 2022-08-02
• Last updated: 2022-08-05

Locations

2 sites across 1 country: China