RecruitingPhase 3NCT07797218

Neoadjuvant Pyrotinib-to-pertuzumab in HER2+ eBC

Neoadjuvant Pyrotinib, Trastuzumab, Docetaxel Followed by Pertuzumab, Trastuzumab, Docetaxel Versus Pertuzumab, Trastuzumab, Docetaxel for the Treatment of Early or Locally Advanced HER2-Positive Breast Cancer: A Randomized, Multicenter, Open-Label Study

Sponsor

Shanghai Jiao Tong University School of Medicine

Enrollment

220 participants

Start Date

Jul 1, 2026

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Summary

This is a randomized, open-label, superiority, multicenter clinical trial for patients with early or locally advanced (T≥2cm, N0-3, M0) HER2-positive breast cancer. It aims to compare the efficacy of neoadjuvant treatment with 2 cycles of Pyrotinib + Trastuzumab + Docetaxel followed by 2 cycles of Pertuzumab + Trastuzumab + Docetaxel versus 4 cycles of Pertuzumab + Trastuzumab + Docetaxel. Exploratory analyses of ctDNA clearance rate and MRI response will also be conducted.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Docetaxel, a drug called Pertuzumab, and others for people with breast cancer early stage breast cancer (stage 1-3). The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years to 70 Years.

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.

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