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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Drug: cytotoxic chemotherapy (docetaxel or epirubicin or cyclophosphamide or carboplatin)
anti-Her2 monoclonal antibody (Trastuzumab, Pertuzumab)
traditional herbal medicine
ShengJing ospital of China Medical University
Shenyang, Liaoning, China
RECRUITINGShengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning, China
RECRUITINGTotal pathological complete response rate (tpCR)
The disappearance of all invasive tumours in the breast and axillary lymph nodes
Time frame: One month after surgery
Global health status and functioning subscales
Health-related quality of life (HRQoL) was measured using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30; version 3).
Time frame: One month after surgery
Cancer-related fatigue scores
Piper Fatigue Scale will be used to measure cancer-related fatigue. The scale scores were measured:at baseline, at the end of cycles 2 and 4, and before surgery. Each score represents the degree of fatigue: a score of 0 means none, 1-3 means mild, 4-6 means moderate, 7-10 means severe.
Time frame: One month after surgery
Adverse events (AE) and serious adverse events (SAE)
For adverse events (AE) and serious adverse events (SAE), refer to NCI-CTC AE 5.0 standard.
Time frame: Period of neoadjuvant therapy (treatment 1-6 months)
Disease free survival (DFS)
Disease-free survival (DFS) is the time from the day of enrollment to the first occurrence of recurrent disease, including second primary malignancies in the non-breast area and breast ductal carcinoma in situ.
Time frame: 5 years
Five-year overall survival (OS)
Five-year overall survival (OS) is the time from the random date to death due to any cause.
Time frame: 5 years
Expression of immune cells
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Expression of immune cells (T cell, B cell, NK cell )
Time frame: One month after surgery
Expression of cytokines (IL, INF-r, TNF-a)
Expression of cytokines (IL, INF-r, TNF-a)
Time frame: One month after surgery