RecruitingPhase 2NCT07340398

Neoadjuvant Trastuzumab-rezetecan Plus Pertuzumab or Nab-Paclitaxel, Carboplatin, Trastuzumab, and Pyrotinib After Suboptimal Response to Neoadjuvant Dual HER2-Targeted Therapy Combined With Chemotherapy in HER2-Positive Early Breast Cancer

Neoadjuvant Trastuzumab-rezetecan Plus Pertuzumab or Nab-Paclitaxel, Carboplatin, Trastuzumab, and Pyrotinib After Suboptimal Response to Neoadjuvant Dual HER2-Targeted Therapy Combined With Chemotherapy in HER2-Positive Early Breast Cancer: A Response-Guided Phase II Study (TAYLOR)


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

200 participants

Start Date

Dec 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This prospective, response-guided phase II study investigates individualized neoadjuvant treatment strategies for patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. After receiving neoadjuvant dual-HER2-targeted therapy with chemotherapy, patients are evaluated for their treatment response. Those achieving an adequate response continue the therapy, whereas patients with a suboptimal response transition to an intensified investigational regimen incorporating novel targeted agents. This adaptive approach aims to optimize pathologic response, minimize unnecessary toxicity, and explore more effective treatment options for individuals with insufficient benefit from conventional neoadjuvant therapy.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new combination of treatments given before breast cancer surgery (called neoadjuvant therapy) for people with HER2-positive early breast cancer who did not respond well enough to initial standard pre-surgery treatment. It compares two different drug combinations to find the most effective approach. **You may be eligible if...** - You are 18–75 years old - You have HER2-positive early breast cancer (stage I–III) confirmed by biopsy - You have already received standard neoadjuvant HER2-targeted therapy and chemotherapy but did not have a complete response - Your cancer has not spread to distant organs - Your heart and other organ functions are adequate - You are not pregnant **You may NOT be eligible if...** - You received prior cancer treatment for breast cancer before starting neoadjuvant therapy - You have bilateral breast cancer, inflammatory breast cancer, or an unconfirmed diagnosis - Your cancer has spread beyond the breast and nearby lymph nodes 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

DRUGNab paclitaxel

Nab paclitaxel

DRUGCarboplatin

carboplatin

DRUGTrastuzumab

trastuzumab

DRUGPertuzumab

pertuzumab

DRUGSHR-A1811

a HER2-targeted antibody-drug conjugate (ADC)

DRUGPyrotinib

Pyrotinib: an oral irreversible pan-HER tyrosine kinase inhibitor (TKI).


Locations(1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, China

View Full Details on ClinicalTrials.gov

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

Visit

NCT07340398


Related Trials