A Single-Arm Clinical Study to Evaluate the Efficacy and Safety of Neoadjuvant Oral Paclitaxel Plus Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Injection in Patients With HER2-positive Breast Cancer

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to evaluate the efficacy and safety of oral paclitaxel plus fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in the neoadjuvant treatment of HER2+ breast cancer patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

⁃ Aged 18-70 years old. Histologically confirmed HER2-positive invasive breast cancer with clinical stages T1c-4, N0-3, and M0 (excluding T1cN0M0), according to the 8th American Joint Committee on Cancer (AJCC) edition BC staging system HER2 overexpression was defined as immunohistochemistry (IHC) 3+ or 2+ with HER2 gene amplification, determined by fluorescence in situ hybridization (FISH).

⁃ Baseline left ventricular ejection fraction (LVEF) of ≥50%. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.

⁃ The functional level of major organs must meet the following requirements (no blood transfusion and no use of white blood cell, red blood cell and platelet-raising drugs within 2 weeks before the first dose):

• Absolute neutrophil count ≥ 1,500/mcL

• Platelets ≥ 100,000/mcL

• Hemoglobin ≥ 9.0 g/dL

• Total bilirubin ≤ 1.5 x upper limit of normal (ULN)

• Alanine aminotransferase and aspartate aminotransferase (ALT/AST) ≤1.5×ULN

• Blood urea nitrogen and serum creatinine ≤1.5×ULN

• Creatinine clearance (Ccr) ≥50 ml/min (Cockcroft-Gault formula) Signature of informed consent

Locations
Other Locations
China
Peking University Cancer Hospital
NOT_YET_RECRUITING
Beijing
Guangdong Women and children Hospital
NOT_YET_RECRUITING
Guangzhou
Sun Yat-sen Memorial Hospital
RECRUITING
Guangzhou
The Affiliated Hospital of Guizhou Medical University
NOT_YET_RECRUITING
Guiyang
Hainan Central Hospital
NOT_YET_RECRUITING
Haikou
Guangxi Provincial Cancer Hospital
NOT_YET_RECRUITING
Nanning
Cancer Hospital of Shantou University Medical College
NOT_YET_RECRUITING
Shantou
Peking University Shenzhen Hospita
NOT_YET_RECRUITING
Shenzhen
the First Affiliated Hospital of Wenzhou Medical University
NOT_YET_RECRUITING
Wenzhou
Contact Information
Primary
Qiang Liu, PhD
liuqiang_sysu@163.com
86-13922251256
Backup
Yudong Li, PhD
649046236@qq.com
86+15989295289
Time Frame
Start Date: 2025-08-15
Estimated Completion Date: 2029-06-30
Participants
Target number of participants: 112
Treatments
Experimental: Oral Paclitaxel plus Subcutaneous Pertuzumab/Trastuzumab
Paclitaxel oral solution plus subcutaneous fixed-dose combination of pertuzumab and trastuzumab
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborators: Cancer Hospital of Guangxi Medical University, Nanfang Hospital, Southern Medical University, Hainan People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Affiliated Cancer Hospital of Shantou University Medical College, Peking University Cancer Hospital & Institute, Peking University Shenzhen Hospital, The Affiliated Hospital Of Guizhou Medical University, Guangdong Women and Children Hospital

This content was sourced from clinicaltrials.gov