ClinicalTrials.gov
public full text
Public Domain
HER2-positive Breast Cancer Without Intravenous Neoadjuvant Therapy
1. The primary goal of this clinical trial is to evaluate the pathological complete response (pCR) rate of oral paclitaxel solution combined with subcutaneous pertuzumab and trastuzumab in the neoadjuvant treatment of early or locally advanced HER2-positive breast cancer.This trial also aims to evaluate the safety profile, breast-conserving surgery rate after neoadjuvant therapy, and long-term efficacy of this combination regimen. 2. Study Interventions All enrolled patients will receive neoadjuvant combination treatment for 6 cycles (21 days per cycle) as follows: * Oral paclitaxel solution: 200 mg/m² orally twice daily on Day 1 and Day 8 of each cycle, for a total of 6 cycles. * Subcutaneous pertuzumab and trastuzumab fixed-dose combination: Administered subcutaneously on Day 1 of each cycle for 6 cycles. The loading dose is 15 mL (1200 mg pertuzumab + 600 mg trastuzumab), and the maintenance dose is 10 mL (600 mg pertuzumab + 600 mg trastuzumab). After surgery, the subsequent adjuvant treatment will be determined by the investigator based on pathological response status and the latest clinical guidelines. 3. Participant Procedures (Consistent with Provided Example Structure) The main questions this study aims to answer are: * Does oral paclitaxel solution combined with subcutaneous dual HER2 blockade improve the pCR rate in patients with HER2-positive early or locally advanced breast cancer? * What are the safety profiles and tolerability of this oral chemotherapy plus subcutaneous targeted combination regimen? * Can this regimen improve breast-conserving surgery rate and provide favorable long-term survival outcomes? 4. Participants will: * Take oral paclitaxel solution and receive subcutaneous dual-target injection per study schedule for 6 neoadjuvant cycles * Complete regular on-site clinic visits, physical examinations, and laboratory tests throughout the treatment period * Undergo standardized pathological evaluation afte
Conceptio Open Archive
Analyze & explore related research in Conceptio
Connect this record directly into your research workflow or AI agent. Explore citations across open repositories, query full text, and export structured proof bundles.
This document is indexed with metadata only: full text is not available in the archive for this record. Open the official source ↗
Related documents
- Neoadjuvant Oral Paclitaxel Plus Subcutaneous Pertuzumab/Trastuzumab in Patients With HER2-positive Breast Cancer#1124690
- This Study Aims to Optimize Neoadjuvant Therapy for HER2-positive Breast Cancer by Implementing a Dynamic Monitoring-guided Treatment Strategy.#807342
- Neoadjuvant trastuzumab deruxtecan alone or followed by paclitaxel, trastuzumab, and pertuzumab for high-risk HER2-positive early breast cancer (DESTINY-Breast11): a randomised, open-label, multicentre, phase III trial#412759
- The Efficacy and Safety of Neoadjuvant Trastuzumab Plus Taxane With and Without Pertuzumab Therapy#825165
- Neoadjuvant TDM1 With Lapatinib and Abraxane Compared With Trastuzumab Plus Pertuzumab With Paclitaxel#899071
Record · ID 1140332
Retrieved via Conceptio: every document is proof-bundled with source, license, and retrieval metadata.
Retrieved via Conceptio: every document is proof-bundled with source, license, and retrieval metadata.
Bring this data into your agent: Connect via MCP or API · 20 free credits to start · no card required
Read the Docs → · View CLI source on GitHub · Conceptio Open Knowledge Archive
Read the Docs → · View CLI source on GitHub · Conceptio Open Knowledge Archive