RecruitingPhase 3NCT07196774

A Trial of SHR-A1811 Compared to Other Antitumor Therapies as Neoadjuvant Treatments in Early-stage or Locally Advanced HER2-positive Breast Cancer

A Randomized, Open-label, Multicenter Phase III Study of SHR-A1811 Compared to Docetaxel+Carboplatin+Trastuzumab+Pertuzumab as a Neoadjuvant Therapy for the Initial Treatment of Early-stage or Locally Advanced HER2-positive Breast Cancer


Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Enrollment

740 participants

Start Date

Oct 23, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a multicenter, randomized, open-label, parallel Phase III clinical trial. 650 early-stage or locally advanced breast cancer participants will be enrolled and randomly assigned to SHR-A1811 monotherapy group (trial group) or TCbHP treatment group (control group) at a 1:1 ratio. Participants will receive neoadjuvant treatments of SHR-A1811 or TCbHP, while those who have completed neoadjuvant therapy and are suitable for surgery must undergo surgical treatment. The participants will be evaluated on tumor efficacy through postoperative pathological assessment by IRC and pathologists from the research center. The primary endpoint will be tpCR evaluated by IRC. Participants who complete surgical treatment will be followed up for at least 3 years at study endpoints such as EFS, DFS, and DDFS.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new antibody-drug combination (SHR-A1811) as a treatment given before surgery for women with early-stage or locally advanced HER2-positive breast cancer. HER2-positive means the cancer has a protein that makes it grow faster. The goal is to see how well this treatment shrinks the tumor before surgery. **You may be eligible if...** - You are a woman aged 18–75 receiving treatment for the first time - Your breast cancer is confirmed HER2-positive by a pathology test - You are in generally good health (ECOG score 0–1) - You agree to use contraception and have a negative pregnancy test **You may NOT be eligible if...** - Your cancer is HER2-negative - You have already received cancer treatment - You are allergic to the study drug - You are currently enrolled in another clinical trial - You have received a vaccine within 30 days before starting treatment 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

DRUGSHR-A1811 for Injection

SHR-A1811 for injection.

DRUGDocetaxel injection

Docetaxel injection.

DRUGTrastuzumab Injection

Trastuzumab injection.

DRUGCarboplatin for Injection

Carboplatin for injection.

DRUGPertuzumab Injection

Pertuzumab injection.


Locations(2)

Shengjing Hospital, China Medical University

Shenyang, Liaoning, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

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

Visit

NCT07196774