RecruitingPhase 2NCT05911958

A Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer

Phase II Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer

Sponsor

Henan Cancer Hospital

Enrollment

66 participants

Start Date

Jul 5, 2023

Study Type

INTERVENTIONAL

Conditions

HER2 Low Breast Carcinoma

Summary

HR-positive breast cancers accounts for about 50% to 60% of all breast cancer patients. Neoadjuvant Chemotherapy is the core treatment mode for this type of breast cancer, and endocrine therapy can be used in some low-risk patients. However, the pathological complete response (pCR) rate obtained is low. HER2 is an important prognostic indicator and therapeutic target for breast cancer. Nearly 60% of HR-positive breast cancers have low expression of HER2, and antibody-drug conjugates (ADC) targeting HER2 may achieve better efficacy in this subtype.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new antibody-drug combination (SHR-A1811) given before surgery (neoadjuvant therapy) for a type of breast cancer that is hormone-positive but has low levels of the HER2 protein. **You may be eligible if...** - You are 18–70 years old - You have untreated breast cancer (stage T2–T3, no distant spread) - Your cancer is hormone receptor-positive and HER2-low - Your cancer's Ki-67 activity marker is above 14% - You have good general health (ECOG 0–1) **You may NOT be eligible if...** - You have already received treatment for this breast cancer - Your cancer is HER2-high or has spread to distant organs - You have heart problems, lung disease, or serious liver/kidney issues - You are pregnant or breastfeeding 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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