This study was designed to evaluate the efficacy and safety of pyrotinib combined with albumin paclitaxel and trastuzumab in the treatment of Her2-positive early or locally advanced breast cancer, and to explore RCB scores and TILs expression and other related molecular markers for pyrrole the efficacy of the treatment with pyrotinib.
At present, the treatment mode of breast cancer has gradually turned to the individualized comprehensive treatment mode combining systemic therapy and local therapy, and neoadjuvant therapy is widely used. Albumin-bound paclitaxel alters the excipients, reduces adverse reactions and greatly enhances efficacy, facilitating clinical applications. Studies have shown that in the use of neoadjuvant chemotherapy, drugs containing purple shirts and anthracyclines will be the drug of choice. The HER2/erbB2 molecule is an independent prognostic factor for breast cancer. About 20%-30% of adenocarcinoma patients have amplification/overexpression of HER2 gene. These patients are insensitive to conventional therapy and are more prone to recurrence and metastasis. Shorter survival and poorer prognosis. Current drugs targeting HER2 targets mainly include macromolecular monoclonal antibodies and their conjugates and small molecule tyrosine kinase inhibitors. Pyrotinib is an irreversible inhibitor of small targets (EGFR and HER2). Compared with trastuzumab, it has different sites of action, which may lead to synergy in the treatment of human Her2-positive breast cancer. The excellent clinical efficacy of dual-targeted neoadjuvant therapy for Her2 positive breast cancer, the anti-tumor effect and good tolerance of pyrotinib, we intend to develop a pyrotinib combined with albumin paclitaxel and trastuzumab one-arm exploratory clinical study of neoadjuvant therapy for Her2-positive early or locally advanced breast cancer with the aim of assessing efficacy and safety, and exploring the efficacy of tumor-associated molecular markers such as RCB scores and TILs expression for pyrotinib treatment predicting effectiveness.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
400mg/d,po qd,q3w, 4 cycles
125mg/m2,ivggt,d1,q3w,4 cycles.
The first week load dose 4mg / kg, followed by 2mg / kg per week, d1,ivggt,q3w,4 cycles.
West China Hospital, Sichuan University
Chengdu, Chengdu, Sichuan, China, China
RECRUITINGpathologic Complete Response(pCR)(ypT0/is N0)
Invasive tumor residuals in the breast and axillary lymph nodes without microscopic examination, ductal carcinoma in situ may exist.
Time frame: Postoperative evaluation after completion of neoadjuvant therapy (approximately 24 weeks) .
Overall Response Rate (ORR)
The proportion of patients with a best overall confirmed response of CR or PR in the whole body as assessed per RECIST 1.1 by the investigator.
Time frame: up to 2 years
Disease Control Rate (DCR)
The proportion of patients with a best overall response of CR, PR or SD in the whole body, as assessed per RECIST1.1 by the investigator.
Time frame: up to 2 years
Residual Cancer Burden (RCB)
The RCB category (RCB-0, RCB-I, RCB-II, or RCB-III) was defined according to the M.D. Anderson Cancer Center standard, and the RCB score was associated with the patient's prognosis.
Time frame: up to 2 years
Tumor Infiltrating Lymphocytes (TILS)
This outcome measure is designed to measure the amount of TILs in newly diagnosed luminal A and Triple Negative Breast Cancer (TNBC) tumors. The mean percent change in TILS in tumor tissue from initial core biopsy samples will be compared with pathology samples from definitive surgery after IORT between the two different breast cancer sub types.
Time frame: up to 2 years
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