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.
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)
History of invasive breast cancer. Bilateral breast cancer or inflammatory breast cancer . Prior excisional and/or incisional biopsy of the primary tumor and/or axillary lymph nodes.
Unstable angina;
Clinically significant arrhythmias requiring medication;
Myocardial infarction within the past 6 months;
Single group
Paclitaxel oral solution plus Subcutaneous Pertuzumab/Trastuzumab
DrugPatients who meet the inclusion criteria will be enrolled and given paclitaxel oral solution and subcutaneous pertuzumab/trastuzumab for neoadjuvant treatment. Paclitaxel oral solution: 200mg/m2 po bid, D1,D8,D15, q3w. Subcutaneous pertuzumab/trastuzumab: 1200 mg pertuzumab plus 600 mg trastuzumab loading dose in 15 mL, followed by 600 mg pertuzumab plus 600 mg trastuzumab maintenance doses in 10 mL, q3w.
Total Pathological Complete Response(tpCR)
It refers to the absence of any invasive cancer in the resected specimens (breast + axilla) after completion of neoadjuvant chemotherapy and surgery (i.e., ypT0/is, ypN0).
Overall Response Rate(ORR)
Tumor assessments were made based upon the Response Evaluation Criteria in Solid Tumors (RECIST) criteria - version 1.1. ORR includes both partial response (PR) and complete response (CR).
Event-Free Survival (EFS)
EFS is defined as the time from randomization to any of the following events: disease progression during neoadjuvant treatment, disease recurrence, or any cause of death.
Overall survival(OS)
Overall survival is defined as the time from treatment start until death from any cause.
Health Related Quality of Life (QoL)
To evaluate changes in health related quality of life (QoL) assessments from baseline in all subjects using the Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores in each dimension are uniformly transformed to dimensions ranging from 0 to 100. For functional and global quality of life scales, higher scores mean a better level of functioning. For symptom-oriented scales, a higher score means more severe symptoms.
Click on the lead sponsor to view all of their trials.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead sponsor
Peking University Cancer Hospital & Institute
Collaborator
Peking University Shenzhen Hospital
Collaborator
Hainan People's Hospital
Collaborator
The Affiliated Hospital Of Guizhou Medical University
Collaborator
Nanfang Hospital, Southern Medical University
Collaborator
Guangdong Women and Children Hospital
Collaborator
Affiliated Cancer Hospital of Shantou University Medical College
Collaborator
First Affiliated Hospital of Wenzhou Medical University
Collaborator
Cancer Hospital of Guangxi Medical University
Collaborator
