RecruitingPhase 2NCT06340230

SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive/HER2 Low Breast Cancer

A Phase II Study of SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive/HER2 Low Breast Cancer


Sponsor

Shengjing Hospital

Enrollment

93 participants

Start Date

Aug 23, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open-label, phase II study evaluating the efficacy and safety of SHR-A1811 alone or in combination with Adebrelimab in Stage II-III HR Positive/HER2 Low Breast Cancer. Subjects will receive the neoadjuvant therapy of SHR-A1811 alone or in combination with Adebrelimab 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 new combination of drugs — SHR-A1811 (an antibody-drug combination targeting HER2) with or without adebrelimab (an immunotherapy drug) — as pre-surgery (neoadjuvant) treatment for a specific subtype of breast cancer that is hormone receptor-positive but has low HER2 expression. **You may be eligible if...** - You are a woman aged 18 to 75 - You have been diagnosed with hormone receptor-positive (HR+), HER2-low invasive breast cancer, confirmed by biopsy - Your cancer is stage II or III and you have not received any prior treatment - Your overall health status is good (ECOG 0 or 1) - Your organ function is adequate **You may NOT be eligible if...** - You have received any prior anti-cancer treatment for this cancer - You have bilateral (both breasts), inflammatory, or hidden (occult) breast cancer - Your cancer is stage IV (metastatic) - You have had any other cancer in the past 5 years (except cured cervical cancer in situ or treated melanoma skin cancer) - You have a history of immunodeficiency, serious heart disease, interstitial lung disease, active hepatitis, or a bleeding/clotting disorder - You participated in another drug clinical trial within the past 4 weeks 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 Injection + Adebrelimab Injection

Drug: SHR-A1811 Injection Drug: Adebrelimab Injection

DRUGSHR-A1811 Injection + Adebrelimab Injection

Drug: SHR-A1811 Injection Drug: Adebrelimab Injection

DRUGSHR-A1811 Injection

Drug: SHR-A1811 Injection


Locations(1)

Shengjing Hospital affiliated to China Medical University

Shenyang, Liaoning, China

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NCT06340230


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