A Phase II Study of SHR-A1811 Combined With Radiotherapy in HER2-positive and HER2-low Breast Cancer Brain Metastases

Launched by WUHAN UNION HOSPITAL, CHINA · May 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called SHR-A1811 combined with radiotherapy for women with advanced breast cancer that has spread to the brain. Specifically, it focuses on patients whose cancer tests positive for a protein called HER2, either at high levels (HER2-positive) or lower levels (HER2-low). The goal is to see how effective and safe this combination of treatments is for managing brain metastases, which are cancer cells that have spread to the brain.

To be eligible for this trial, women must be over 18 years old, have confirmed HER2-positive or HER2-low breast cancer, and have newly diagnosed brain metastases, with fewer than six spots in the brain. They should also have had no more than four previous treatments for advanced breast cancer and must be in good health overall. Participants can expect to receive the study treatment along with standard radiotherapy, and they will need to attend regular check-ups to monitor their health and response to the treatment. This trial is currently not recruiting, but it aims to help improve future treatment options for women facing this challenging situation.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Pathologically confirmed HER2 positive (IHC 3+ or IHC 2+/FISH+)or HER2-low(IHC1+ or 2+/FISH-) advanced breast cancer
• • 2. Age\>18 years.
• • 3. newly diagnosed Brain metastases confirmed by enhanced brain MRI. Metastases number less than 6.
• • 4. No more than four lines of previous advanced therapy
• • 5. Life expectancy of more than 3 months
• • 6. There were no known or suspected leptomeningeal brain metastases
• • 7. The interval from previous therapy was more than 2 weeks, and acute toxicity from previous therapy had to resolve to grade 1 or less
• • 8. The use of mannitol, bevacizumab, or hormone therapy was allowed before enrollment, but the dose was stable for at least a week without the need for an increment
• 9. Screening laboratory values must meet the following criteria( and should be obtained within 28 days prior to registration):
• • Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L, Platelets≥ 90 x 109/L, Hemoglobin ≥ 90 g/L Aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≤2.5 x ULN without liver metastasis,≤ 5 x ULN with liver metastases Serum BUN and creatinine ≤ 1.5 x Upper Limit of Normal (ULN) LVEF ≥ 50% QTcF \< 480 ms INR≤1.5×ULN，APTT≤1.5×ULN 10.Signed the informed consent form prior to patient entry
• Exclusion Criteria:
• • 1. Leptomeningeal or hemorrhagic metastases
• • 2. previously used T-dxd
• • 3. Uncontrolled epilepsy
• • 4. Severe or uncontrolled disease: severe cardiovascular disease, end-stage renal disease, severe hepatic disease, history of immunodeficiency, including HIV positive, active HBV/HCV or other acquired congenital immunodeficiency disease, or organ transplantation history, active infection, etc.
• • 5. History of allergy to treatment regimens
• • 6. Pregnancy or lactation period， women of child-bearing age who are unwilling to accept contraceptive measures.
• • 7. Inability to complete enhanced MRI
• • 8. Not suitable for inclusion for specific reasons judged by sponsor -