RecruitingPhase 3NCT06126640

A Phase III, Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy

A Phase III, Multicenter, Randomized, Open-Label, Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy


Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Enrollment

1,600 participants

Start Date

Nov 20, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants with Residual Invasive Disease Following Neoadjuvant Therapy,This study will examine SHR-A1811versus trastuzumab emtansine (T-DM1) in patients with HER2-positive primary breast cancer who have residual invasive disease in breast or axillary lymph nodes after neoadjuvant therapy.The primary objective is to compare invasive disease-free survival (IDFS) between SHR-A1811 and T-DM1 treatment arms in this population. The key secondary objective of the study is to evaluate disease-free survival (DFS), overall survival (OS) and distant recurrence-free interval (DRFI).


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing a new antibody-drug therapy (SHR-A1811) to the standard treatment (T-DM1) in women with HER2-positive breast cancer who still had cancer remaining after their pre-surgery chemotherapy. **You may be eligible if...** - You are a woman aged 18–75 with HER2-positive breast cancer confirmed by pathology - You had at least 6 cycles of pre-surgery chemotherapy including at least 9 weeks of trastuzumab (anti-HER2 therapy) - You still had cancer in the breast or lymph nodes after surgery - Your surgery was completed 3–12 weeks before starting the study drug - You have good overall health based on lab tests **You may NOT be eligible if...** - You had complete clearance of cancer after surgery (pathologic complete response) - You received fewer cycles of pre-surgery chemotherapy than required - Your cancer stage before treatment was T1N0 (very small tumor, no lymph node involvement) 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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Interventions

DRUGSHR-A1811

Lyophilized powder injection, 100mg / bottle, intravenous drip

DRUGTrastuzumab Emtansine

Lyophilized powder injection, 160mg / bottle, 100mg / bottle, intravenous drip


Locations(2)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06126640