Neoadjuvant Oral Paclitaxel Plus Subcutaneous Pertuzumab/Trastuzumab in Patients With HER2-positive Breast Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Paclitaxel oral solution plus Subcutaneous Pertuzumab/Trastuzumab

Treatment groups

112 Participants
are divided into 1 treatment group

Sponsors and collaborators

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