NCT04152057

Pyrotinib Maleate Tablets Combined With Albumin Paclitaxel and Trastuzumab for Her2-positive Breast Cancer

A Single-arm, Exploratory Clinical Study of Pyrotinib Maleate Tablets Combined With Albumin Paclitaxel and Trastuzumab for Her2-positive Early or Locally Advanced Breast Cancer and Its Biomarkers

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer
• HER2 Positive
• Combination Chemotherapy

Interventions

Type	Name	Description
DRUG	Pyrotinib Maleate Tablets	400mg/d,po qd,q3w, 4 cycles
DRUG	Albumin Paclitaxel	125mg/m2,ivggt,d1,q3w,4 cycles.
DRUG	Trastuzumab	The first week load dose 4mg / kg, followed by 2mg / kg per week, d1,ivggt,q3w,4 cycles.

Timeline

• Start date: 2019-11-01
• Primary completion: 2020-04-01
• Completion: 2021-04-01
• First posted: 2019-11-05
• Last updated: 2019-11-05

Locations

1 site across 1 country: China