RecruitingNot ApplicableNCT07095023

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

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


Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

112 participants

Start Date

Aug 15, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of oral paclitaxel (a chemotherapy pill) with subcutaneous (under-the-skin injection) versions of pertuzumab and trastuzumab — targeted antibody drugs — given before surgery in people with HER2-positive breast cancer. HER2-positive means the cancer cells have higher than normal levels of a protein that drives their growth. The goal is to shrink the tumor before surgery. **You may be eligible if...** - You are 18 to 70 years old - You have been diagnosed with HER2-positive invasive breast cancer (confirmed by biopsy) at a stage that can be treated before surgery - Your heart function is normal or near normal (ejection fraction of 50% or higher) - You are in good general health (ECOG 0 or 1) - You have not previously been treated for breast cancer **You may NOT be eligible if...** - You have had a prior invasive breast cancer or have inflammatory breast cancer - You have already had a biopsy that removed the main tumor mass - You have a history of severe allergic reactions to any of the study drugs - You have had a heart attack, stroke, or uncontrolled high blood pressure in the past 6 months - You have conditions that would prevent you from swallowing oral medication (e.g., bowel obstruction, Crohn's disease) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPaclitaxel oral solution plus Subcutaneous Pertuzumab/Trastuzumab

Patients 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.


Locations(9)

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Guangdong Women and children Hospital

Guangzhou, Guangdong, China

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, China

Guangxi Provincial Cancer Hospital

Nanning, Guangxi, China

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Hainan Central Hospital

Haikou, Hainan, China

the First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Peking University Shenzhen Hospita

Shenzhen, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07095023


Related Trials