A Phase II Study of SHR-A1811 Combined With Radiotherapy in HER2-positive and HER2-low Breast Cancer Brain Metastases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-A1811 and radiotherapy.
- Who it may be relevant to
- Registry conditions: Breast Cancer Metastatic. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
SHR-A1811 Combined With Radiotherapy in HER2-positive and HER2-low Breast Cancer Brain Metastases: a Prospective，Sigle-arm，Phase II Study
Overview
A prospective, single-arm study to explore the efficacy and safety of SHR-A1811 combined with radiotherapy in patients with HER2-positive or HER2-low brain metastases
Interventions
- Combination product SHR-A1811 and radiotherapy
SHR-A1811:4.8mg/kg radiotherapy: 800cGY\*5
Primary outcome measures
- The objective response rate of intracranial（IC-ORR） [Time frame: 2 years]
Secondary outcome measures (4)
- Intracranial CNS Progression Free Survival(IC-PFS) [Time frame: 2 years]
- Progression Free Survival(PFS) [Time frame: 2 years]
- Overall survival(OS) [Time frame: 3 years]
- Adverse Events [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- Pathologically confirmed HER2 positive (IHC 3+ or IHC 2+/FISH+)or HER2-low(IHC1+ or 2+/FISH-) advanced breast cancer
- Age>18 years.
- newly diagnosed Brain metastases confirmed by enhanced brain MRI. Metastases number less than 6.
- No more than four lines of previous advanced therapy
- Life expectancy of more than 3 months
- There were no known or suspected leptomeningeal brain metastases
- The interval from previous therapy was more than 2 weeks, and acute toxicity from previous therapy had to resolve to grade 1 or less
- 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
- 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
- Leptomeningeal or hemorrhagic metastases
- previously used T-dxd
- Uncontrolled epilepsy
- 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.
- History of allergy to treatment regimens
- Pregnancy or lactation period， women of child-bearing age who are unwilling to accept contraceptive measures.
- Inability to complete enhanced MRI
- Not suitable for inclusion for specific reasons judged by sponsor -
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06975462 · UH-SHR A1811 and radiotherapy