RecruitingPhase 2NCT05635487

A Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients

A Phase II Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients

Sponsor

Shengjing Hospital

Enrollment

65 participants

Start Date

Mar 16, 2023

Study Type

INTERVENTIONAL

Conditions

HER2-positive Breast Cancer

Summary

This is a phase II trial evaluating the efficacy and safety of SHR-A1811 monotherapy or combined with pyrotinib maleate in Stage II-III HER2-positive breast cancer. Subjects will receive the neoadjuvant therapy of SHR-A1811 monotherapy or combined with pyrotinib for six cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. Efficacy will be assessed every 2 cycles.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called SHR-A1811 (alone or combined with pyrotinib) as a pre-surgery treatment (neoadjuvant therapy) for women with HER2-positive breast cancer. The goal is to shrink the tumor before surgery to improve surgical outcomes. **You may be eligible if...** - You are a woman between 18 and 75 years old - You have HER2-positive invasive breast cancer (stage II or III) - You have not yet received any treatment for your breast cancer - You are in good general health (ECOG score 0 or 1) **You may NOT be eligible if...** - You have previously received any cancer treatment (chemotherapy, radiation, or targeted therapy) - Your cancer is stage I or IV - You have poor organ function 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.

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